How Excessive Regulation Helped Ignite COVID-19's Rampant Spread
When historians of the future look back at the 2020 pandemic, the heroic work of Helen Y. Chu, a flu researcher at the University of Washington, will be worthy of recognition.
Chu's team bravely defied the order and conducted the testing anyway.
In late January, Chu was testing nasal swabs for the Seattle Flu Study to monitor influenza spread when she learned of the first case of COVID-19 in Washington state. She deemed it a pressing public health matter to document if and how the illness was spreading locally, so that early containment efforts could succeed. So she sought regulatory approval to adapt the Flu Study to test for the coronavirus, but the federal government denied the request because the original project was funded to study only influenza.
Aware of the urgency, Chu's team bravely defied the order and conducted the testing anyway. Soon they identified a local case in a teenager without any travel history, followed by others. Still, the government tried to shutter their efforts until the outbreak grew dangerous enough to command attention.
Needless testing delays, prompted by excessive regulatory interference, eliminated any chances of curbing the pandemic at its initial stages. Even after Chu went out on a limb to sound alarms, a heavy-handed bureaucracy crushed the nation's ability to roll out early and widespread testing across the country. The Centers for Disease Control and Prevention infamously blundered its own test, while also impeding state and private labs from coming on board, fueling a massive shortage.
The long holdup created "a backlog of testing that needed to be done," says Amesh Adalja, an infectious disease specialist who is a senior scholar at the Johns Hopkins University Center for Health Security.
In a public health crisis, "the ideal situation" would allow the government's test to be "supplanted by private laboratories" without such "a lag in that transition," Adalja says. Only after the eventual release of CDC's test could private industry "begin in earnest" to develop its own versions under the Food and Drug Administration's emergency use authorization.
In a statement, CDC acknowledged that "this process has not gone as smoothly as we would have liked, but there is currently no backlog for testing at CDC."
Now, universities and corporations are in a race against time, playing catch up as the virus continues its relentless spread, also afflicting many health care workers on the front lines.
"Home-testing accessibility is key to preventing further spread of the COVID-19 pandemic."
Hospitals are attempting to add the novel coronavirus to the testing panel of their existent diagnostic machines, which would reduce the results processing time from 48 hours to as little as four hours. Meanwhile, at least four companies announced plans to deliver at-home collection tests to help meet the demand – before a startling injunction by the FDA halted their plans.
Everlywell, an Austin, Texas-based digital health company, had been set to launch online sales of at-home collection kits directly to consumers last week. Scaling up in a matter of days to an initial supply of 30,000 tests, Everlywell collaborated with multiple laboratories where consumers could ship their nasal swab samples overnight, projecting capacity to screen a quarter-million individuals on a weekly basis, says Frank Ong, chief medical and scientific officer.
Secure digital results would have been available online within 48 hours of a sample's arrival at the lab, as well as a telehealth consultation with an independent, board-certified doctor if someone tested positive, for an inclusive $135 cost. The test has a less than 3 percent false-negative rate, Ong says, and in the event of an inadequate self-swab, the lab would not report a conclusive finding. "Home-testing accessibility," he says, "is key to preventing further spread of the COVID-19 pandemic."
But on March 20, the FDA announced restrictions on home collection tests due to concerns about accuracy. The agency did note "the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection," while adding that "we are actively working with test developers in this space."
After the restrictions were announced, Everlywell decided to allocate its initial supply of COVID-19 collection kits to hospitals, clinics, nursing homes, and other qualifying health care companies that can commit to no-cost screening of frontline workers and high-risk symptomatic patients. For now, no consumers can order a home-collection test.
"Losing two months is close to disastrous, and that's what we did."
Currently, the U.S. has ramped up to testing an estimated 100,000 people a day, according to Stat News. But 150,000 or more Americans should be tested every day, says Ashish Jha, professor and director of the Harvard Global Health Institute. Due to the dearth of tests, many sick people who suspect they are infected still cannot get confirmation unless they need to be hospitalized.
To give a concrete sense of how far behind we are in testing, consider Palm Beach County, Fla. The state's only drive-thru test center just opened there, requiring an appointment. The center aims to test 750 people per day, but more than 330,000 people have already called to try to book a slot.
"This is such a rapidly moving infection that losing a few days is bad, and losing a couple of weeks is terrible," says Jha, a practicing general internist. "Losing two months is close to disastrous, and that's what we did."
At this point, it will take a long time to fully ramp up. "We are blindfolded," he adds, "and I'd like to take the blindfolds off so we can fight this battle with our eyes wide open."
Better late than never: Yesterday, FDA Commissioner Stephen Hahn said in a statement that the agency has worked with more than 230 test developers and has approved 20 tests since January. An especially notable one was authorized last Friday – 67 days since the country's first known case in Washington state. It's a rapid point-of-care test from medical-device firm Abbott that provides positive results in five minutes and negative results in 13 minutes. Abbott will send 50,000 tests a day to urgent care settings. The first tests are expected to ship tomorrow.
Patients voice hope and relief as FDA gives third-ever drug approval for ALS
At age 52, Glen Rouse suffered from arm weakness and a lot of muscle twitches. “I first thought something was wrong when I could not throw a 50-pound bag of dog food over the tailgate of my truck—something I use to do effortlessly,” said the 54-year-old resident of Anderson, California, about three hours north of San Francisco.
In August, Rouse retired as a forester for a private timber company, a job he had held for 31 years. The impetus: amyotrophic lateral sclerosis, or ALS, a progressive neuromuscular disease that is commonly known as Lou Gehrig’s disease, named after the New York Yankees’ first baseman who succumbed to it less than a month shy of his 38th birthday in 1941. ALS eventually robs an individual of the ability to talk, walk, chew, swallow and breathe.
Rouse is now dependent on ventilation through a nasal mask and uses a powerchair to get around. “I can no longer walk or use my arms very well,” he said. “I can still move my wrists and fingers. I can also transfer from my chair to the toilet if I have two of my friends help me.”
It’s “shocking” that modern medicine has very little to offer to people with this devastating condition, Rouse said. But there is hope on the horizon. Yesterday, the U.S. Food and Drug Administration approved Relyvrio, a drug made up of two parts, sodium phenylbutyrate and taurursodiol, to treat patients with ALS.
“This approval provides another important treatment option for ALS, a life-threatening disease that currently has no cure,” said Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a statement. “The FDA remains committed to facilitating the development of additional ALS treatments.”
Until this point, the FDA had approved only two other medications—Riluzole (rilutek) in 1995 and Radicava (edaravone) in 2017—to extend life in patients with ALS, which typically kills within two to five years after diagnosis. That’s why earlier this week, Rouse was optimistic about the FDA’s likely approval of a controversial new drug for ALS.
When Relyvrio is taken in addition to Riluzole, it appears to slow functional decline by an additional 25 percent and extend life by another 6 to 10 months, said Richard Bedlak, director of the Duke ALS Clinic. “It is not a cure, but it is definitely a step forward.”
“The whole ALS community is extremely excited about it,” he said the day before Relyvrio’s expected approval. “We are very hopeful. We’re on pins and needles.”
A study of 137 ALS patients did not result in “substantial evidence” that Relyvrio was effective, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee concluded in March. However, after some persuasion from FDA officials, patients and their families, the committee met again and decided to recommend approving the drug.
In January 2019, following an ALS diagnosis at age 58 in October the previous year, Jeff Sarnacki, of Chester, Maryland, was accepted into a trial for Relyvrio. “Because of the trial, we did experience hope and a greater sense of help than had we not had that opportunity,” said Juliet Taylor, his wife and caregiver. They both believed the drug “worked for him in giving him more time.”
In June 2019, Sarnacki chose an open-label extension, offered to patients by drug researchers after a study ends, and took the active drug until he died peacefully at home under hospice care in May 2020, five days after his 60th birthday. A retired agent with the federal Bureau of Alcohol, Tobacco, Firearms and Explosives who later worked as a security consultant, Sarnacki lived about 19 months after diagnosis, which is shorter than the typical prognosis.
His symptoms began with leg cramps in fall 2017 and foot drop in early 2018. A feeding tube was placed in 2019, as it became necessary early in his illness, Taylor said. He also took Radicava and Riluzole, the two previously approved drugs, for his ALS. “We were both incredulous that, so many years after Lou Gehrig’s own diagnosis, there were so few treatments available,” she said.
The dearth of successful treatments for ALS is “certainly not for lack of trying,” said Karen Raley Steffens, a registered nurse and ALS support services coordinator at the Les Turner ALS Foundation in Skokie, Ill. “There are thousands of researchers and scientists all over the world working tirelessly to try to develop treatments for ALS.”
Unfortunately, she added, research takes time and exorbitant amounts of funding, while bureaucratic challenges persist. The rare disease also manifests and progresses in many different ways, so many treatments are needed.
As of 2017, the Centers for Disease Control and Prevention estimated that more than 31,000 people in the U.S. live with ALS, and an average of 5,000 people are newly diagnosed every year. It is slightly more common in men than women. Most people are diagnosed between the ages of 55 and 75.
Most cases of ALS are sporadic, meaning that doctors don’t know the cause. There is about a one-year interval between symptom onset and an ALS diagnosis for most patients, so many motor neurons are lost by the time individuals can enroll in a clinical trial, said Richard Bedlack, professor of neurology and director of the Duke ALS Clinic in Durham, North Carolina.
Bedlack found the new drug, Relyvrio, to be “very promising,” which is why he testified to the FDA in favor of approval. (He’s a consultant and disease state speaker for multiple companies including Amylyx, manufacturer of Relyvrio.)
The “drug has different mechanisms of action than the currently approved treatments,” Bedlack said. He added that, when Relyvrio is taken in addition to Riluzole, it appears to slow functional decline by an additional 25 percent and extend life by another 6 to 10 months. “It is not a cure, but it is definitely a step forward.”
T. Scott Diesing, a neurohospitalist and director of general neurology at the University of Nebraska Medical Center in Omaha, said he hopes the drug is “as good as people anticipated it should be, because there are not too many options for these patients.”
"FDA went out on a limb in approving Relyvrio based on limited results from a small trial while a larger study remains in progress," said Florian P. Thomas, co-director of the ALS Center at Hackensack University Medical Center and Hackensack Meridian School of Medicine in New Jersey. "While it is definitely promising, clearly, the last word on this drug has not been spoken."
So far, Rouse's voice is holding up, but he knows the day will come when ALS will steal that and much more from him.
ALS is 100 percent fatal, with some patients dying as soon as a year after diagnosis. A few have lasted as long as 15 years, but those are the exceptions, Diesing said.
“If this drug can provide even months of additional life, or would maintain quality of life, that’s a big deal,” he noted, adding that “the patients are saying, ‘I know it’s not proven conclusively, but what do we have to lose?’ So, they would like to try it while additional studies are ongoing.” The drug has already been conditionally approved in Canada.
As his disease progresses, Rouse hopes to get a speech-to-text voice-generating computer that he can control with his eyes. So far, his voice is holding up, but he knows the day will come when ALS will steal that and much more from him. He works at I AM ALS, a patient-led community, and six of his friends have already died of the disease.
“Every time I lose a friend to ALS, I grieve and am sad but I resolve myself to keep working harder for them, myself and others,” Rouse said. “People living with ALS find great purpose in life advocating and trying to make a difference.”
Friday Five Podcast: New drug may slow the rate of Alzheimer's disease
The Friday Five covers important stories in health and science research that you may have missed - usually over the previous week, but today's episode is a lookback on important studies over the month of September.
Most recently, on September 27, pharmaceuticals Biogen and Eisai announced that a clinical trial showed their drug, lecanemab, can slow the rate of Alzheimer's disease. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend and the new month.
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This Friday Five episode covers the following studies published and announced over the past month:
- A new drug is shown to slow the rate of Alzheimer's disease
- The need for speed if you want to reduce your risk of dementia
- How to refreeze the north and south poles
- Ancient wisdom about Neti pots could pay off for Covid
- Two women, one man and a baby