August 26, 2020 – For this superpower, I have to thank Alcoholics Anonymous. I joined AA at 19 mostly because I loved cocaine, truly loved cocaine, but also because I loved vodka and cheap white wine and diet pills and valium in enormous quantities. I wanted to not die, so joining was an easy decision, helped along by the knowledge that I came from a family of female alcoholics: My mother had written novels about her drinking, and my grandmother was famous for her drunken vomiting at various fine restaurants throughout Manhattan. So, on November 1, 1997, I boarded a plane for the Hazelden treatment center in Minnesota. Soon after, I began attending AA meetings, which I still attend to this day, though on Zoom right now.
Like so many things in AA, the “One day at a time” mantra seemed nonsensical at first and later became gospel. Thinking I can’t have a drink ever again or even I can’t have a drink this week is sometimes too much, but I can’t have a drink today is manageable. Over the past 23 years, I’ve worked to trick my brain into staying in the moment, and not dwelling on the future or the past.
August 27, 2020 – Filming the heavier scenes during the feud: “There was some heavy stuff there in the beginning, especially with the wreck scenario. It was just very heavy stuff. I’m always interested as everybody is different in so far as how the viewer feels watching at home, especially hardcore fans of mine. Even thinking back to the stuff with CM Punk when I was failing drugs tests, they turned it into a storyline and that’s what I mean when I talk about roller-coasters of good and bad. Throughout all of that, so long as I can continue to do good, especially with this, my last chance to get it right, it is going to inspire people around the world that I’ll never meet, that need to stay sober to survive. Hopefully I’m doing that through the television screen and helping people I’ll never know.”
His ideas for the Bar Match with Sheamus: “When the idea of the bar match was thrown out there, I wrote up a whole script of how the match would possibly go. Most of it never happened, but I do love [doing] that. A lot of that stuff I said in that first meeting of me and Sheamus in the bar was stuff I actually wrote … it felt good to have ideas that they liked and bring them to life, just from being involved in the recovery world.”
August 30, 2020 – After the birth of her daughter Adalynn in 2013, Messer found herself suffering from serious and chronic back pain. She was prescribed some pain meds by her doctor, and that quickly escalated into a full-blown addiction to the pain medications. She could no longer live without the pain killers and reported that she sought opportunities to purchase the pills on the street when she so desperately needed more.
KHN senior correspondent Markian Hawryluk joined KUNC’s Erin O’Toole on “Colorado Edition” to discuss his recent story about how the Affordable Care Act is affecting the close Colorado Senate race between incumbent Republican Sen. Cory Gardner and Democratic former Gov. John Hickenlooper. That race and five others involving vulnerable Republican incumbents who sought to repeal the health care law could determine which party controls the U.S. Senate in 2021.
Public sentiment about the health care law, also known as Obamacare, has shifted. What was a political liability in 2014 for candidates has become a selling point amid the loss of jobs and health insurance for millions of people during the coronavirus pandemic.
SACRAMENTO — After years of failed attempts and vociferous opposition, California lawmakers on Monday adopted a measure to grant nurse practitioners the ability to practice without doctor supervision — but only after making big concessions to the powerful doctors’ lobby, which nonetheless remains opposed.
The bill now heads to Gov. Gavin Newsom for consideration, fenced in by amendments that would stringently limit how much independence nurse practitioners — nurses with advanced training and degrees — can have to practice medicine.
Lawmakers credit these compromises, like them or not, for finally allowing them to push the issue over the finish line, capping years of political scrapping and perhaps one day altering the delivery of health care in California.
“This is not an intrusion on a hallowed profession, it’s a relief,” said state Sen. John Moorlach (R-Costa Mesa), one of four Republican senators who voted for the bill. Moorlach said the measure would get more practitioners into underserved areas that don’t have enough doctors.
“It’s like the cavalry coming up over the hill to provide reinforcements to a tired army of wonderful and overworked doctors,” he said.
California is behind most other states in empowering nurse practitioners. If the bill becomes law, the state would join nearly 40 others to grant some level of independence to nurse practitioners; 22 grant full independence, according to the American Association of Nurse Practitioners. California would have among the most restrictive policies on nurse practitioner independence in the country.
“I’m not going to say I regret any of these changes,” said Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee and authored the bill, AB-890.
Wood opposed previous attempts to remove supervision requirements.
“I wish it could be a little less strict, quite frankly,” he said, adding that this was a reasonable compromise informed by his experiences as a dentist and what he learned from other providers.
Today, nurse practitioners must enter into a written agreement with a physician to oversee their work with patients. In exchange, physicians bill them between $5,000 and $15,000 per year, according to a report by the California Health Care Foundation and the University of California-San Francisco. (California Healthline is an editorially independent service of the California Health Care Foundation.)
“Where we are with the pandemic and the craziness of the world today, it highlights why there’s a need for this,” said Andrew Acosta, a spokesperson for the California Association for Nurse Practitioners. “The doctor shortage isn’t going away anytime soon.”
Under Wood’s measure, nurse practitioners would be able to see patients in their own practice, but only after working under physician supervision for at least three years. The bill also contains many other restrictions.
Nurse practitioners argue that the measure, even with its limitations, would ease primary care shortages, especially in rural areas — a problem the pandemic has made more stark.
Opponents, primarily the powerful California Medical Association, which is the doctors’ lobbying group, counter that stripping nurse practitioners of physician oversight would lead to a lower standard of care, and that nurse practitioners wouldn’t necessarily flock to rural areas once they’re free of physician supervision.
These arguments aren’t new in Sacramento, but lawmakers and lobbyists say this version of the bill succeeded because there are new leaders at the helm of influential legislative committees who were willing to make changes, and because the pandemic has changed health care.
“I think the legislature is starting to realize decades of evidence that nurse practitioners are safe, productive providers,” said Ed Hernandez, a former legislator who was termed out in 2018 and authored the last two failed bills. “I think the policy is finally overshadowing the politics” of the California Medical Association.
Still, the biggest difference this year is the bill itself. Hernandez’s bills, introduced in 2013 and 2015, were “clean” bills that granted independence to nurse practitioners without many requirements.
There’s nothing clean about Wood’s bill, which was heavily amended in the state Senate. Instead of simply lifting the supervision requirements on nurse practitioners, the measure imposes several hoops for nurse practitioners to jump through. Before they could practice independently, nurse practitioners would have to be certified by preapproved national nursing boards, and possibly complete additional California-specific testing if accredited out of state.
Once certified, they would have to practice under physician supervision for at least three years — up to six in some cases — before they could strike out on their own. And they would have to disclose to patients that they aren’t doctors.
The bill even prescribes a Spanish phrase for “nurse practitioner”: enfermera especializada. (Technically, this refers to a female nurse. The bill doesn’t provide the equivalent phrase for a male nurse.)
That’s not even all the amendments — and the measure wouldn’t take effect until 2023.
The requirements were inserted in response to criticism from the California Medical Association that nurse practitioners are not qualified to provide patient care without physician oversight, and that patients wouldn’t understand that they’re seeing someone with less training than a doctor, lawmakers said.
Despite the numerous amendments, the association remains opposed, saying the changes don’t address their fundamental concerns.
“We’ve increased the training required for physicians over the last couple years and now all of a sudden we’re allowing unsupervised providers to treat patients who have even less training,” said association spokesperson Anthony York.
Rounds of negotiations, major concessions and hourslong Zoom calls still could not get the doctors’ group on board, Wood said.
He said it was like chasing “goalposts that continue to move.”
“It’s very disappointing when you work with opposition and nothing is ever good enough,” Wood said. “CMA will never support this bill. They’ll never go neutral on it.”
York said that characterization is not accurate. He pointed to a different bill — SB-1237 — that would allow certified nurse midwives to attend to low-risk pregnancies without physician supervision. The association was initially opposed, but after negotiations and amendments to the bill, it changed its position to neutral. That bill is also headed to Newsom.
“You don’t have to look too far to find a case where we were willing to engage on a scope-of-practice issue,” York said.
David McCuan, a political science professor at Sonoma State University, called the association’s inability to kill Wood’s bill a political “watershed moment” for the group.
“Their M.O. for 70 years has been about blocking, stunting and preventing change,” McCuan said. “The deference toward the medical profession has changed. In that sense, it would be a momentous event if this is signed.”
Though the California Association for Nurse Practitioners is celebrating legislative passage of the measure, even in its amended form, it’s a different story at the national level. Sophia Thomas, president of the American Association of Nurse Practitioners, said in a statement that the bill is choked by too much red tape to provide any meaningful change.
“California’s so-called ‘solution,’ the flawed AB-890, would establish a cascading set of new restrictions on NP practice that would maintain California’s position among the most heavily regulated and restrictive in the nation,” Thomas said.
State Sen. Richard Pan (D-Sacramento), a pediatrician who chairs the Senate Health Committee, said he also opposed the bill, but not simply because he is a doctor or a member of the California Medical Association.
Yet many of his objections reflect those of the association, such as concerns about training and access to care in rural areas.
He also believes independence for nurse practitioners could exacerbate inequalities in the health care system, as people with less means see providers with less training.
“People with more resources are going to go with the person they think is more qualified. That’s just the way it tends to happen,” Pan said.
California Healthline’s Angela Hart contributed to this report.
SACRAMENTO — California is poised to become the first state to develop its own line of generic drugs, targeting soaring drug prices and stepping into a fiercely competitive drug market dominated by deep-pocketed pharmaceutical companies.
The Democratic-controlled legislature overwhelmingly approved a measure Monday that would direct the state’s top health agency to partner with one or more drug companies by January to make or distribute a broad range of generic or biosimilar drugs — including the diabetes medicine insulin — that are cheaper than brand-name products.
The bill, SB-852, also opens the door for California to make its own generic drugs in the future.
Gov. Gavin Newsom will have until Sept. 30 to sign or veto the measure.
“People need these drugs, but prices are through the roof, so we’re saying there’s a role for the state to bring prices down,” said the bill’s author, state Sen. Richard Pan (D-Sacramento).
He argued the measure is more important than ever because COVID-19 has exposed “glaring gaps” in the ability of public and private entities — from major hospitals to government drug purchasers — to maintain adequate supplies of drugs, medical equipment and devices.
“This also creates a model to address drug shortages and other supply chain issues during COVID and future pandemics,” he said.
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Newsom, a Democrat, floated his own generic drug proposal in January as part of his broader drug agenda to reduce pharmaceutical costs, but was forced to abandon his plan in May as he and lawmakers sought to address a pandemic-induced $54 billion budget deficit.
Though it could take years to successfully bring a new California generic product to the market, the move would put the nation’s most populous state in direct competition with major generic and brand-name drug manufacturers that dominate the market, and potentially allow California to use its massive purchasing power to drive down drug prices.
“Other legislative efforts in Congress and in other states have focused on government negotiating with pharmaceutical companies to lower prices on generic drugs,” said Edwin Park, research professor at the Health Policy Institute at Georgetown University.
The Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers, has taken a neutral position on the bill and declined to comment.
But Brett Michelin, lead lobbyist for the Washington, D.C.-based trade group that represents generic drugmakers, the Association for Accessible Medicines, said generic companies aren’t threatened by the possibility of California entering the market — and even welcome it.
“Generic manufacturers are more than open to doing this kind of partnership,” Michelin said. “I think having a fair and open process to sell drugs and compete for customers is what the generic industry is very used to and comfortable with.”
Under the measure, state-developed generics would be “widely” available to public and private purchasers within California. Taxpayers would pick up the costs, roughly $1 million to $2 million in startup funding, plus ongoing staff costs estimated in the low hundreds of thousands of dollars annually, according to a state fiscal analysis.
It’s unclear which drugs the state would make or procure, though it would target drugs that could produce the biggest cost savings for the state and consumers.
But the bill specifically calls for the production of “at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings.”
Insulin is a biologic drug, made with living cells. Once a biologic hits the market, rival copycat products that follow are called biosimilars.
Three major drug companies — Eli Lilly and Co., Sanofi and Novo Nordisk — have long controlled the lucrative insulin market in the U.S. The state of California would be the first entity to produce a biosimilar version of one of the newer, fast- and long-acting insulins on a not-for-profit basis, said Jane Horvath, a health policy consultant in Washington, D.C.
Although it would be costly and could take years, the Utah-based nonprofit drug company Civica Rx, which has consulted with Pan on his bill, is discussing partnering with California to produce generic or biosimilar drugs. It has already hammered out deals with major health systems running short on critical drugs, including the Department of Veterans Affairs, and is producing lower-cost generics for insurers, including Blue Shield of California.
“There’s no doubt insulin would be a more complex and expensive drug to develop, but it’s certainly possible,” said Allan Coukell, the company’s senior vice president of public policy. “We are watching how the biosimilar market develops.”
Patients who need insulin have faced huge cost spikes. A 2019 report by the Health Care Cost Institute concluded that average prices for insulin doubled from 2012 to 2016. And California health insurance regulators found last year that diabetes medications accounted for nine of the 25 costliest brand-name drugs sold in the state.
“It’s a big deal — diabetes affects a lot of people who rely on insulin for their very lives,” said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. “And insulin has probably been the poster child for unreasonable drug pricing.” (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)
Laura Marston, a Washington, D.C.-based lawyer and diabetic who advocates for lower insulin prices, said she’s excited about California’s idea.
Marston has been on the same insulin, Humalog, since 1996. At that time, the price was $21 a vial, but has since ballooned to more than $275 a vial, she said.
“If there was a lower-cost option and the price wasn’t going to be raised, I would absolutely switch from Humalog,” she said. “I feel held totally hostage to these pharmaceutical companies.”
Marston said she’d like the federal government to do the same thing, “so it could apply to all patients.”
Congressional efforts to tackle rising prices for insulin and other drugs fizzled last year in the face of opposition from the influential pharmaceutical lobby. So states have increasingly sought ways to regulate a for-profit industry in which brand-name manufacturers hold near-monopoly power.
Colorado last year became the first state to cap out-of-pocket insulin costs at $100 for a 30-day supply. It was followed by at least nine other states, from New Mexico to New York, whose cost-sharing caps vary.
California had already capped out-of-pocket drug costs at $250 to $500 for a 30-day supply, but a measure that would have lowered the cap for insulin to $100 a month stalled this year — a casualty of a pandemic-shortened legislative calendar.
Newsom’s office declined to comment on the generic drug legislation. But recent changes to the proposal reflect direct negotiations with the administration, Pan’s office said.
Newsom spokesperson Jesse Melgar said in a statement that “the governor’s goal of a sustainable system of universal coverage has not changed and making prescription drugs affordable is one more step toward that goal.”
Should Newsom sign the bill into law, the state Health and Human Services Agency would have 18 months to identify a list of drugs the state could manufacture, with a report due to the legislature by July 2022. By July the following year, the state would be required to assess whether it can manufacture its own generics and biosimilars.
The bill calls for state health officials to prioritize development of generics for chronic and high-cost health conditions, and urges production of those that can be delivered through mail order.
California could emerge as a leader in the national drug debate, Levitt said.
“If California can pull it off, it would be a model for other states and federally,” he said. “For it to pull this off means it can be done at scale.”
“What activities are open to do next week? Zip-lining? Jet ski? Anyone have recommendations on things still open?” a Facebook user asks.
“Stay home!” another user replies.
The Facebook group called “What’s Going on St. Thomas?” has been flooded with pointed, exasperated comments urging travelers to stay away. This is a marked change. Before the pandemic, the exchanges between vacationers and island residents resonated with promises of excitement and fun. Now, tour operators from the mainland who administer the Facebook page quickly try to delete any expressions of anger.
In nearby Puerto Rico, the friction has spilled into real life. Mediareports have detailed multiple episodes in which tourists, having escaped pandemic restrictions back home, became violent and destroyed store merchandise after being asked to wear a mask.
The COVID-19 pandemic has pitted economic interests against public health guidance all across the United States. Puerto Rico and the Virgin Islands feel this tension acutely, as both U.S. territories rely on tourism to generate revenue and provide jobs. Increasingly, locals have begun to wonder now if welcoming visitors to these islands is worth the risk.
Tourism represents more than half of the Virgin Islands’ gross domestic product. In Puerto Rico, the industry accounts for 80,000 jobs and about 6.5% of the island’s total economy.
But islanders are not only vulnerable to COVID-19’s economic disruptions. Residents of both Puerto Rico and the Virgin Islands are diagnosed with chronic health conditions like diabetes and cardiovascular illness at higher rates than in most U.S. states, which puts them at higher risk for the virus’s complications.
In short, the very industry that represents an economic lifeline for islanders threatens their ability to protect their health.
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One Step Forward
When COVID-19 triggered alarms in late winter, Puerto Rico and the USVI adopted strong COVID prevention strategies before most U.S. states did.
In Puerto Rico, Gov. Wanda Vázquez issued an executive order March 15, effectively locking down the island by imposing a curfew, a stay-at-home order and business closures. The first coronavirus cases on the island were reported March 13.
Similarly, Virgin Islands Gov. Albert Bryan Jr. issued executive orders prohibiting hotels, villas and other accommodations from accepting leisure guests between March 25 and June 1. The area remained open to business travelers, flight crews, health officials, emergency personnel, government guests and residents. According to a March 20 Department of Health update, the territory had — at that time — six confirmed COVID cases and 43 pending test results.
Neither territory, however, was able to close its airports. Local officials do not have the authority to do so because the federal government regulates aviation.
“Part of the challenge of being a U.S. colony, in particular, is that, you know, we don’t have control over our borders,” said Hadiya Sewer, president and co-founder of St. JanCo: the St John Heritage Collective, a cultural heritage preservation and land rights organization on the small island of St. John, U.S. Virgin Islands.
Still, the aggressive measures — while effective — came at a price for residents like Melina Aguilar.
Before the lockdown, the 31-year-old entrepreneur worked as a tour guide for Isla Caribe, a company she founded that offers historical walking tours of Ponce, Puerto Rico. The stay-at-home order in March shut down Aguilar’s business for three months and sequestered her in her house.
Aguilar said the sacrifice would have been worth it if the island could have maintained control of the spread by closing the border and enforcing the 14-day quarantine for travelers. It didn’t work out that way. According to data from The New York Times, the seven-day average for cases on May 1 — while Puerto Rico was still in lockdown — was 42 cases per day. On July 1, the seven-day average was 102 cases. By July 15, the average was 233.
“We could’ve basically had the fruits of being locked up for three months,” Aguilar said. “But now we’re stuck.”
Reopening the Gateway
By summer, both territories were itching to get back to business. With many overseas vacation destinations banning U.S. travelers, it seemed like the nearby mainland would be full of beachgoers, who, after living under stay-at-home orders for months, would be ready to travel — no passport required — to the sun and sand.
The U.S. Virgin Islands formally welcomed tourists back to its shores on June 1 — with caveats. Travelers from coronavirus hot spots needed to submit COVID-19 test information through an online portal to receive a negative result “certification code.” Those who didn’t were required to quarantine for 14 days or until they had documentation of a negative test result.
But locals and tourists alike said COVID enforcement measures haven’t been consistent. Capt. Matthias Bitterwolf, owner of Antillean Yacht Charters on St. Thomas, said he delivered a boat to Puerto Rico and was not allowed off the vessel until local police could verify his COVID paperwork. His COVID status was not checked upon returning to St. Thomas.
The Virgin Islands’ case counts soon began ticking up. Between June and mid-July, the case count increased by more than 3,500%, according to one NBC news report.
Gov. Bryan responded by issuing other executive orders to regain control of the outbreak, including prohibiting beach visits after 4 p.m. and not allowing patrons to stand or eat at bars located in restaurants. As of Aug. 24, the USVI had a total of 984 positive COVID-19 cases and 11 deaths.
Puerto Rico formally welcomed tourists on July 15 while still imposing some COVID-related restrictions. As in the Virgin Islands, officials required travelers to present documentation of a negative COVID test result upon arrival.
Dr. Victor Ramos, president of the island’s medical association who is involved with the island’s medical task force, said these decisions tended to expose the rift “between the medical task force that favors closing things and the economic task force that wants to leave everything open.”
By July, the local economy was in shambles. The Department of Labor reported over 21% of the island’s workforce was receiving unemployment assistance related to the pandemic in the week ending Aug. 1.
But rising case counts attributed to travel prompted local officials to encourage that only essential travel be allowed. As of Aug. 24, the island had recorded over 30,700 COVID cases and at least 395 deaths, according to the New York Times database.
Government data, though, indicated Puerto Rico’s climbing case numbers were not being triggered by tourists. They are not the culprits, insisted Leah Chandler, chief marketing officer of Discover Puerto Rico, the island’s official tourism website. Rather, the spread was linked to island residents coming home after visiting COVID hot spots like Texas and Florida.
Life on the Ground
Despite the global pandemic and the restrictions, both territories have experienced no shortage of vacationers. “We would have expected this to be a slow moment for us in terms of tourism,” said Sewer. “It’s very busy.”
Still, the trend lines for COVID case counts weren’t moving in the right direction for either territory, so it was no surprise when Puerto Rico closed days after reopening and the USVI followed suit on Aug. 19.
The underlying socioeconomic and health issues put residents in both places at high risk. It’s not just the prevalence of chronic health conditions like diabetes and cardiovascular disease. The high number of multigenerational households in both areas complicates a family’s ability to socially distance from its most vulnerable members. Roughly a quarter of the population in Puerto Rico and the Virgin Islands is age 65 or older, and poverty is widespread.
At the same time, both territories have limited health care infrastructure — making it difficult to envision that they can care for their own populations in an emergency let alone visitors who could become ill and island-bound if the virus were to surge.
Currently, the USVI has two main hospitals — one in St. Thomas and one in St. Croix — and a health clinic in St. John. The territory has 20 intensive care unit beds and about 100 one-time-use ventilators for its 106,235 residents, said Justa Encarnacion, the USVI’s health commissioner. Each island has about 30 full-capacity ventilators.
In Puerto Rico, about 60% of the island’s ventilators for adults were available as of Aug. 24. However, ICU beds are harder to come by, said Ramos. They are filled with COVID patients and those whose conditions worsened after avoiding care out of fear of catching the virus, he said.
The string of problems that have besieged these islands magnifies the effects of the pandemic. That includes debt crises and infrastructure damage from hurricanes and earthquakes. Island residents also fear the possibility of battling a hurricane and a coronavirus outbreak at the same time — a reality that they’ve already confronted when COVID hampered the USVI’s emergency management agency’s ability to distribute sandbags ahead of a storm in late July.
Colorado State University hurricane researchers predict an “extremely active” 2020 Atlantic hurricane season.
“At this point, we literally have disasters layered on top of disasters,” said Sewer, of the St. John’s Collective.
Still, Joseph Boschulte, tourism commissioner for the Virgin Islands, is cautiously optimistic about finding a balance between health and economic interests.
“We appreciate the concerns of our tourism partners and stakeholders,” he said. But with the spike in cases, he said, “we must reset, take stock, safeguard human life and prepare for restarting our tourism economy at a later date.”
August 29, 2020 – As he did at last year’s inaugural event, Father Neal Longe of St. Ann’s Episcopal Church will lead the crowd in prayer, while candles will be provided by Betz, Rossi & Bellinger Funeral Home and both signs and stickers will be provided by Sticker Mule.
“We’re looking forward to educating individuals about the stigma [of addiction],” Hill said. “It could be my family, it could be yours. It could be a neighbor, it could be a parent’s neighbor. It could be anyone, at any time, anywhere.” “It’s great that we do this every year,” she added, “but this something that we should be doing daily.”
According to the state Department of Health’s most recent County Opioid Quarterly Report issued in January, there were nine opioid overdose deaths in Montgomery County in 2018, and two from January through June 2019.
Montgomery County launched a task force last year to combat the opioid epidemic, as between 2015 to 2017 the county had the highest opioid prescription rate in the state, according to the Department of Health.
Combating the negative stigma of addiction is one key step to addressing the problem, Hill said, as is increasing the availability of and training for the use of Narcan (naxolone), the nasal spray that can be used to treat decreased breathing during an opioid overdose.
In the United States, the average wait time for COVID-19 test results is about four days. Even worse, 10 percent of individuals don’t receive lab results for 10 days or more.
Quick reporting of test results helps identify infected individuals so they and anyone they potentially spread the coronavirus to can be isolated, preventing further spread of the virus.
“If you have a 14-day lag to knowing if someone is actually sick and contagious, then they’ll interact with many, many more people in that period than if you have a one-day or a six-hour or one-hour turnaround,” says Omar Abudayyeh, a bioengineer at MIT.
Abudayyeh is among the many researchers and companies racing to develop new and speedier types of diagnostic tests that circumvent clinical labs altogether. Some of these tests complete their analyses in all-in-one machines that are portable enough to be set up in schools, nursing homes and offices. Several companies are developing tests like these that can diagnose COVID-19 in 30 minutes or less, with a level of accuracy comparable to lab tests. Others are harnessing the power of the gene editor CRISPR to deliver rapid results.
And another type of test, made by Abbott Laboratories and granted emergency use authorization by the U.S. Food and Drug Administration on August 26, works more like a pregnancy test. All it requires is a test card the size of a credit card, a few drops of a reaction solution and a sample from a nasal swab. Within 15 minutes, two lines appear on the card if the sample contains the virus; one line appears if it doesn’t.
The gold standard
The current gold standard for accurate COVID-19 testing is PCR, or polymerase chain reaction, which can detect even tiny quantities of the virus’s genetic material, RNA (SN: 3/6/20).
The test requires collecting viral RNA directly from the patient, typically gathered using a swab inserted deep into the nasal cavity. At a clinical laboratory, the virus’s RNA is converted to DNA and then run through a specialized instrument that heats and cools that DNA to multiply copies of it, making it easier to detect. After repeating the process for around an hour, if DNA shows up, the sample is considered positive for SARS-CoV-2, the virus that causes COVID-19.
Such tests are fairly accurate. They miss some people very early in the infection or because of lab errors, producing false negatives, meaning that the test results indicate someone isn’t infected when they really are. False positives — when tests wrongly indicate an uninfected person has the virus — are rare with this type of technology. So if a PCR test indicates a person is infected, they probably do carry the virus. The main drawback is the speed. It typically takes days to get results back, and backups at labs can drag the process out for a week or two.
Some people find the nasal probe uncomfortable, so other lab tests have been developed that rely on less invasive samples. On August 15, the FDA authorized a saliva-based test, SalivaDirect, for emergency use. This isn’t the first test to detect the SARS-CoV-2 virus in saliva, which is easier to collect than samples from nasal passages. But its simplified protocol speeds up sample preparation and bypasses testing supplies that have been in short supply in recent months. SalivaDirect, however, is not a rapid test. It still requires processing by clinical laboratories, which contributes to the wait time between providing a sample and receiving results.
To develop faster tests, companies are taking a variety of approaches. Funding for some of this work comes from the Rapid Acceleration of Diagnostics initiative, or RADx, from the National Institutes of Health, which has invested $248.7 million in seven companies tackling testing challenges.
Compact instruments, such as Mesa Biotech’s Accula test, replace the function of clinical labs and could bring rapid testing to schools, nursing homes and offices.Mesa Biotech
San Diego–based Mesa Biotech, for instance, received RADx funding to manufacture a PCR test that replaces an entire clinical lab with a handheld dock and a single-use cartridge. The company says the proprietary technology in its Accula test, which has already received FDA emergency use authorization, can provide a COVID-19 diagnosis in just 30 minutes.
Turning on the LAMP
Other RADx-funded companies, such as Talis Biomedical, headquartered in Menlo Park, Calif., aren’t using PCR to amplify SARS-CoV-2 viral material. The Talis One system instead uses LAMP, or loop-mediated isothermal amplification. In a typical LAMP assay, a patient’s nasal or oral swab sample is mixed with enzymes and specially designed DNA fragments, then heated to 65° Celsius to copy the viral RNA to DNA and produce many more DNA copies. With the Talis test, samples are placed in a cassette, popped into a specialized dock, and analyzed in just 30 minutes.
As opposed to an instrument that cycles between hot and cold, LAMP heats the reaction to one temperature. “You could run the reaction in a water bath,” says Nathan Tanner, a molecular biologist at New England Biolabs in Ipswich, Mass.
In general, LAMP-based diagnostic tests aren’t quite as sensitive as ones based on PCR, Tanner says, but could be used to test more people, given their simpler requirements. In one newly described LAMP testing method, a solution changes color in the presence of 100 or more SARS-CoV-2 RNA molecules. The authors, who describe the test August 12 in Science Translational Medicine, propose that the approach, which didn’t detect the lowest viral loads, would be suitable for identifying individuals with a moderate to high viral load.
Telltale proteins
A third RADx-funded test provides results in a mere 15 minutes. Rather than detecting viral RNA, the test, by Quidel, based in San Diego, detects proteins from virus particles. These viral proteins are also antigens, meaning they stimulate immune responses when they invade our bodies. Such antigen tests are similar to ones used in doctors’ offices and pharmacies to diagnose people with influenza.
Don’t confuse antigen tests with an antibody test that detects antibodies a person develops in response to an infection (SN: 4/28/20) Much like a pregnancy test, COVID-19 antigen tests use antibodies to detect the viral proteins and give a yes or no answer, says Kim Hamad-Schifferli, a bioengineer at the University of Massachusetts Boston.
The Quidel Sofia SARS antigen test has been authorized for emergency use. Like the other RADx-funded rapid tests, it uses a dock and single-use cartridges: Instead of making a line on stick the way a pregnancy test does, the dock detects a fluorescent signal if SARS-CoV-2 proteins are present.
An antigen test by Abbott Laboratories requires only a test card, a swab sample and a few drops of a reaction solution to return a COVID-19 diagnosis in 15 minutes.Abbott
Abbott Laboratories’ test granted emergency use authorization August 26 also is an antigen test and, with its card-based technology, is even simpler. Abbott, based in Abbott Park, Ill., said its test was able to detect 34 of 35 COVID-19-positive patients with symptoms, or 97 percent, in initial studies.
The benefit: An antigen test doesn’t require any specialized lab instruments or enzymes. “It’s all self-contained,” Hamad-Schifferli says. Without a step to amplify viral material, however, an antigen test can be less sensitive than PCR or LAMP and result in a higher rate of false-negative results, up to 20 percent per the FDA’s emergency use authorization guidelines for antigen tests.
That’s because people may produce widely varying amounts of virus, depending on how long has passed since they became infected. In most people, the coronavirus is most abundant from a couple of days after infection to about nine days into the illness (SN: 3/13/20). After that, the immune system kicks in, preventing viruses from being made. On the other hand, viral RNA can be detectable in some people for more than a month. A negative result from an antigen test has a higher chance of being false comfort, so the FDA says that diagnosis may need to be confirmed with another type of test, like PCR.
A new kind of rapid test
Even though antigen tests typically are not as accurate as standard PCR or the new rapid tests, they could play a crucial role helping to end the pandemic — if their use becomes widespread. As of now, though, even Abbott’s 15-minute test still needs to be ordered by a doctor and performed in a health care setting, so that can provide hurdles to its use. But what if people didn’t even have to leave home to get a test?
That’s what Hamad-Schifferli and her colleagues are working on. The idea is to build a cheaper test that doesn’t involve a dedicated instrument — just a paper strip and a signal detectable by eye. Such a simple test could be used more widely by people at home. “It would be a game changer,” she says.
If COVID-19 tests are deployed widely enough, they could serve as a public health measure to identify people with high levels of SARS-CoV-2 and spreading the virus to others, even if they’re not displaying symptoms. That’s because frequent and fast tests can be used to pinpoint outbreaks as they are happening (SN: 7/1/20). If cheap enough, these tests could be used by people daily, catching any missed detections through repeated rounds of testing.
But for daily, population-wide testing that could alert people when they first start transmitting the coronavirus to be adopted, a test needs to be cheap enough — for instance, under a dollar — for many people to use them frequently. Abbott said its tests would cost $5. Quidel’s test cartridges cost $23 apiece and the other RADx-funded rapid tests are likely in a similar price range. Given their higher accuracy, those tests could serve a separate purpose: to conclusively determine if an individual is infected and ensure they receive treatment.
With overwhelming demand for COVID-19 testing, it can take days or even longer than a week for people to receive test results.Hoptocopter/E+/Getty Images
The holy grail of tests may be one that is fast, easy, accurate and inexpensive and that could be used broadly — even by people at home. One group of scientists may be among those nearing that goal. The work is led by Abudayyeh, Jonathan Gootenberg and Feng Zhang, all bioengineers at the McGovern Institute for Brain Research at MIT. Zhang is also at the Broad Institute of MIT and Harvard University.
The team adapted an FDA-authorized test by Sherlock Biosciences in Cambridge, Mass., that uses the gene-editing tool CRISPR. All someone has to do is add a sample — either from a nasal swab or saliva — to a tube with a reaction solution, heat the tube to 60° C for an hour in a pot of water, then add a paper test strip to the tube. If two lines appear, that means SARS-CoV-2 RNA is present.
The readout relies on activity of a CRISPR enzyme, Cas12b. If SARS-CoV-2 RNA is present in the reaction, Cas12b cuts what’s called a reporter, a short piece of DNA that’s labeled on both ends. The two halves of the reporter then wick up the paper strip to different places and appear as two lines. If viral RNA isn’t present, the reporter remains intact and wicks up the strip to one place, showing up as one line.
The new test, STOPCovid, is not yet authorized for clinical use, but based on tests in a small number of patients, it identifies SARS-CoV-2 cases as well as PCR tests, the researchers reported May 8 in a preprint posted at medRxiv.org. It returns results in about an hour and would cost under $10, they say.
Unlike rapid tests relying on docks and cartridges, the STOPCovid test is uniquely designed to scale up to millions of tests per week, says Gootenberg. “There’s never been a demand for millions or tens of millions of tests per week — ever.”
With the development of so many new technologies to test for the coronavirus, “we’re going to come away from the epidemic with a whole new field of diagnostics,” Mina says.
As a veteran who served back-to-back tours in Iraq, I initially cringed when commentators compared the COVID-19 crisis to wartime — no bullets, no blood and no one volunteered for this.
But after my months of reporting on the pandemic, it has become painfully clear this is like war. People are dying every day as a result of government decisions — and indecision — and the death toll is climbing with no end in sight.
Less than six months into the pandemic, COVID-19 has already killed at least 183,000 Americans, more than triple the number who died in the Vietnam War, and far more than the wars in Iraq and Afghanistan combined.
We are all being asked to make sacrifices for the good of our country. And we’re experiencing, as a nation, a deeply traumatic event. Like war, the toll will be felt for a long time.
In California, local public health officials are leading the front lines in this battle against COVID-19, dictating strategy, issuing orders and developing tactics to carry out that strategy. Every day, they make gut-wrenching calls to protect our health and livelihoods, even if those decisions may inflict initial harm on the economy or contradict politicians and popular opinion.
But instead of being celebrated for their difficult and dangerous work, as I was, they are now facing violent threats and political attacks from those who disagree with their tactics — such as requiring masks in public and ordering businesses and parks closed to prevent the spread of infection.
When I interview them, often late at night, I hear in their voices that familiar mix of emotions that often come with war: exhaustion, anxiety and devotion to duty.
“We’ve become easy scapegoats for people’s fear and anxiety during COVID-19,” said Dr. Gail Newel, the health officer for Santa Cruz County, who continues to face threats for issuing public health orders.
The latest — a menacing email sent to her in late July calling her a “communist bitch” — prompted local law enforcement to recommend she get a guard dog and firearm to protect herself. “That weighs very heavily,” she said.
I can’t imagine the burden. Although many of us serving in Iraq disagreed with the war, we remained dedicated to our mission and enjoyed broad support at home.
I joined the military as a U.S. Army reservist in 1999 and was deployed on active duty to Iraq in early 2003, when it truly was like the Wild West.
Serving first as logistics clerk and then the acting supply sergeant for a military police company out of San Jose, California, I helped ensure my military brothers and sisters had proper equipment. When the George W. Bush administration sent us to Iraq, for example, it did so without armoring our Humvees — a major failure that elevated our risk of being blown up by roadside explosives.
I returned home in July 2004 and spent years putting the battlefield behind me as I transitioned to a career in journalism. But living through COVID-19 has resurrected those feelings of being at war.
Now, just like then, there is an overall sense of fear and uncertainty because we don’t know when the crisis will end. We aren’t free to go about our lives as we once did and we yearn for the comforts we took for granted. We miss our loved ones we can’t see.
We must remain hyper-vigilant to potential threats, and even make sure to don our “armor” when we leave our homes, except now it’s masks and gloves instead of helmets and flak jackets.
There’s something that happens when you’re in a conflict zone — the air feels heavier. You can feel threats all around you, just waiting to strike. There’s deep anxiety for what the future holds, and you wonder whether you’ll be alive next week or next month.
Public health officers are shouldering the added anxiety that duty brings. For much of the pandemic, Gov. Gavin Newsom has pushed the responsibility — and blame — of reopening largely onto counties and the state’s 61 local health officers, who have worked for months without days off, giving up time with their families to attack this crisis head-on.
I have interviewed dozens of them. Some have broken into tears while talking with me, and worry chokes their voices as they lament problems with testing or explain how they don’t have enough supplies or contact tracers to safely reopen. They felt rushed into lifting stay-at-home restrictions in May and June, yet they had no choice in the face of pressure from politicians and suffering residents and businesses. After years of severe underfunding, public health agencies don’t have the money or resources to deploy an adequate response.
They’re also wrestling with the guilt and trauma that come with making decisions that affect people’s lives and livelihoods.
“It has been hard on all of us,” acknowledged Sacramento County’s health officer, Dr. Olivia Kasirye. “We’re getting phone calls daily from people saying they’re going bankrupt and they can’t pay their rent and they have loved ones who are dying that they can’t see.”
I know how that feels, having been conflicted about our long-term strategy in the Middle East and the harm we inadvertently inflicted on innocent civilians. But I can’t imagine being afraid of the people I signed up to protect.
Public health officials have become targets of aggressive and personal attacks. Some have seen their photos smeared with Hitler mustaches, while others have had their personal phone numbers and home addresses circulated publicly, prompting the need for round-the-clock security.
“Imagine treating American soldiers and military families with the kind of hatred and disrespect that local health officers are facing,” said Dr. Charity Dean, unprompted, a day after she left her job as one of the top public health officials in the Newsom administration. “They’re the ones taking all the risk, and it makes me angry to see how they’ve been treated.”
Mimi Hall, Newel’s boss and Santa Cruz County’s top public health official, told me law enforcement is investigating a threatening letter addressed to her that was allegedly signed by a far-right anti-government extremist group.
In response, Hall considered retiring early. But she didn’t want to abandon her troops and wasn’t going to let fear stop her from doing her job. So she had a perimeter fence and home security system installed over the weekend — and reported for work promptly Monday morning.
Yes, we are waging a life-or-death battle in which innocent people are hurt, but it’s these battle-scarred public health officers who are making deeply personal sacrifices to steer us to safety.
We commemorate military leaders with medals and parades. Why not treat our public health officials with the same level of appreciation?
