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.
How to Measure Your Stress, with Dr. Rosalind Picard
Today’s podcast guest is Rosalind Picard, a researcher, inventor named on over 100 patents, entrepreneur, author, professor and engineer. When it comes to the science related to endowing computer software with emotional intelligence, she wrote the book. It’s published by MIT Press and called Affective Computing.
Dr. Picard is founder and director of the MIT Media Lab’s Affective Computing Research Group. Her research and engineering contributions have been recognized internationally. For example, she received the 2022 International Lombardy Prize for Computer Science Research, considered by many to be the Nobel prize in computer science.
Through her research and companies, Dr. Picard has developed wearable sensors, algorithms and systems for sensing, recognizing and responding to information about human emotion. Her products are focused on using fitness trackers to advance clinical quality treatments for a range of conditions.
Meanwhile, in just the past few years, numerous fitness tracking companies have released products with their own stress sensors and systems. You may have heard about Fitbit’s Stress Management Score, or Whoop’s Stress Monitor – these features and apps measure things like your heart rhythm and a certain type of invisible sweat to identify stress. They’re designed to raise awareness about forms of stress such as anxieties and anger, and suggest strategies like meditation to relax in real time when stress occurs.
But how well do these off-the-shelf gadgets work? There’s no one more knowledgeable and experienced than Rosalind Picard to explain the science behind these stress features, what they do exactly, how they might be able to help us, and their current shortcomings.
Dr. Picard is a member of the National Academy of Engineering and a Fellow of the National Academy of Inventors, and a popular speaker who’s given over a hundred invited keynote talks and a TED talk with over 2 million views. She holds a Bachelors in Electrical Engineering from Georgia Tech, and Masters and Doctorate degrees in Electrical Engineering and Computer Science from MIT. She lives in Newton, Massachusetts with her husband, where they’ve raised three sons.
In our conversation, we discuss stress scores on fitness trackers to improve well-being. She describes the difference between commercial products that might help people become more mindful of their health and products that are FDA approved and really capable of advancing the science. We also talk about several fascinating findings and concepts discovered in Dr. Picard’s lab including the multiple arousal theory, a phenomenon you’ll want to hear about. And we explore the complexity of stress, one reason it’s so tough to measure. For example, many forms of stress are actually good for us. Can fitness trackers tell the difference between stress that’s healthy and unhealthy?
Show links:
- Dr. Picard’s book, Affective Computing
- Dr. Picard’s bio
- Dr. Picard on Twitter
- Dr. Picard’s company, Empatica - https://www.empatica.com/ - The FDA-cleared Empatica Health Monitoring Platform provides accurate, continuous health insights for researchers and clinicians, collected in the real world
- Empatica Twitter
- Dr. Picard and her team have published hundreds of peer-reviewed articles across AI, Machine Learning, Affective Computing, Digital Health, and Human-computer interaction.
- Dr. Picard’s TED talk
Rosalind Picard
If you look back on the last century of scientific achievements, you might notice that most of the scientists we celebrate are overwhelmingly white, while scientists of color take a backseat. Since the Nobel Prize was introduced in 1901, for example, no black scientists have landed this prestigious award.
The work of black women scientists has gone unrecognized in particular. Their work uncredited and often stolen, black women have nevertheless contributed to some of the most important advancements of the last 100 years, from the polio vaccine to GPS.
Here are five black women who have changed science forever.
Dr. May Edward Chinn
Dr. May Edward Chinn practicing medicine in Harlem
George B. Davis, PhD.
Chinn was born to poor parents in New York City just before the start of the 20th century. Although she showed great promise as a pianist, playing with the legendary musician Paul Robeson throughout the 1920s, she decided to study medicine instead. Chinn, like other black doctors of the time, were barred from studying or practicing in New York hospitals. So Chinn formed a private practice and made house calls, sometimes operating in patients’ living rooms, using an ironing board as a makeshift operating table.
Chinn worked among the city’s poor, and in doing this, started to notice her patients had late-stage cancers that often had gone undetected or untreated for years. To learn more about cancer and its prevention, Chinn begged information off white doctors who were willing to share with her, and even accompanied her patients to other clinic appointments in the city, claiming to be the family physician. Chinn took this information and integrated it into her own practice, creating guidelines for early cancer detection that were revolutionary at the time—for instance, checking patient health histories, checking family histories, performing routine pap smears, and screening patients for cancer even before they showed symptoms. For years, Chinn was the only black female doctor working in Harlem, and she continued to work closely with the poor and advocate for early cancer screenings until she retired at age 81.
Alice Ball
Pictorial Press Ltd/Alamy
Alice Ball was a chemist best known for her groundbreaking work on the development of the “Ball Method,” the first successful treatment for those suffering from leprosy during the early 20th century.
In 1916, while she was an undergraduate student at the University of Hawaii, Ball studied the effects of Chaulmoogra oil in treating leprosy. This oil was a well-established therapy in Asian countries, but it had such a foul taste and led to such unpleasant side effects that many patients refused to take it.
So Ball developed a method to isolate and extract the active compounds from Chaulmoogra oil to create an injectable medicine. This marked a significant breakthrough in leprosy treatment and became the standard of care for several decades afterward.
Unfortunately, Ball died before she could publish her results, and credit for this discovery was given to another scientist. One of her colleagues, however, was able to properly credit her in a publication in 1922.
Henrietta Lacks
onathan Newton/The Washington Post/Getty
The person who arguably contributed the most to scientific research in the last century, surprisingly, wasn’t even a scientist. Henrietta Lacks was a tobacco farmer and mother of five children who lived in Maryland during the 1940s. In 1951, Lacks visited Johns Hopkins Hospital where doctors found a cancerous tumor on her cervix. Before treating the tumor, the doctor who examined Lacks clipped two small samples of tissue from Lacks’ cervix without her knowledge or consent—something unthinkable today thanks to informed consent practices, but commonplace back then.
As Lacks underwent treatment for her cancer, her tissue samples made their way to the desk of George Otto Gey, a cancer researcher at Johns Hopkins. He noticed that unlike the other cell cultures that came into his lab, Lacks’ cells grew and multiplied instead of dying out. Lacks’ cells were “immortal,” meaning that because of a genetic defect, they were able to reproduce indefinitely as long as certain conditions were kept stable inside the lab.
Gey started shipping Lacks’ cells to other researchers across the globe, and scientists were thrilled to have an unlimited amount of sturdy human cells with which to experiment. Long after Lacks died of cervical cancer in 1951, her cells continued to multiply and scientists continued to use them to develop cancer treatments, to learn more about HIV/AIDS, to pioneer fertility treatments like in vitro fertilization, and to develop the polio vaccine. To this day, Lacks’ cells have saved an estimated 10 million lives, and her family is beginning to get the compensation and recognition that Henrietta deserved.
Dr. Gladys West
Andre West
Gladys West was a mathematician who helped invent something nearly everyone uses today. West started her career in the 1950s at the Naval Surface Warfare Center Dahlgren Division in Virginia, and took data from satellites to create a mathematical model of the Earth’s shape and gravitational field. This important work would lay the groundwork for the technology that would later become the Global Positioning System, or GPS. West’s work was not widely recognized until she was honored by the US Air Force in 2018.
Dr. Kizzmekia "Kizzy" Corbett
TIME Magazine
At just 35 years old, immunologist Kizzmekia “Kizzy” Corbett has already made history. A viral immunologist by training, Corbett studied coronaviruses at the National Institutes of Health (NIH) and researched possible vaccines for coronaviruses such as SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).
At the start of the COVID pandemic, Corbett and her team at the NIH partnered with pharmaceutical giant Moderna to develop an mRNA-based vaccine against the virus. Corbett’s previous work with mRNA and coronaviruses was vital in developing the vaccine, which became one of the first to be authorized for emergency use in the United States. The vaccine, along with others, is responsible for saving an estimated 14 million lives.