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.
After his grandmother’s dementia diagnosis, one man invented a snack to keep her healthy and hydrated.
On a visit to his grandmother’s nursing home in 2016, college student Lewis Hornby made a shocking discovery: Dehydration is a common (and dangerous) problem among seniors—especially those that are diagnosed with dementia.
Hornby’s grandmother, Pat, had always had difficulty keeping up her water intake as she got older, a common issue with seniors. As we age, our body composition changes, and we naturally hold less water than younger adults or children, so it’s easier to become dehydrated quickly if those fluids aren’t replenished. What’s more, our thirst signals diminish naturally as we age as well—meaning our body is not as good as it once was in letting us know that we need to rehydrate. This often creates a perfect storm that commonly leads to dehydration. In Pat’s case, her dehydration was so severe she nearly died.
When Lewis Hornby visited his grandmother at her nursing home afterward, he learned that dehydration especially affects people with dementia, as they often don’t feel thirst cues at all, or may not recognize how to use cups correctly. But while dementia patients often don’t remember to drink water, it seemed to Hornby that they had less problem remembering to eat, particularly candy.
Where people with dementia often forget to drink water, they're more likely to pick up a colorful snack, Hornby found. alzheimers.org.uk
Hornby wanted to create a solution for elderly people who struggled keeping their fluid intake up. He spent the next eighteen months researching and designing a solution and securing funding for his project. In 2019, Hornby won a sizable grant from the Alzheimer’s Society, a UK-based care and research charity for people with dementia and their caregivers. Together, through the charity’s Accelerator Program, they created a bite-sized, sugar-free, edible jelly drop that looked and tasted like candy. The candy, called Jelly Drops, contained 95% water and electrolytes—important minerals that are often lost during dehydration. The final product launched in 2020—and was an immediate success. The drops were able to provide extra hydration to the elderly, as well as help keep dementia patients safe, since dehydration commonly leads to confusion, hospitalization, and sometimes even death.
Not only did Jelly Drops quickly become a favorite snack among dementia patients in the UK, but they were able to provide an additional boost of hydration to hospital workers during the pandemic. In NHS coronavirus hospital wards, patients infected with the virus were regularly given Jelly Drops to keep their fluid levels normal—and staff members snacked on them as well, since long shifts and personal protective equipment (PPE) they were required to wear often left them feeling parched.
In April 2022, Jelly Drops launched in the United States. The company continues to donate 1% of its profits to help fund Alzheimer’s research.
Last week, researchers at the University of Oxford announced that they have received funding to create a brand new way of preventing ovarian cancer: A vaccine. The vaccine, known as OvarianVax, will teach the immune system to recognize and destroy mutated cells—one of the earliest indicators of ovarian cancer.
Understanding Ovarian Cancer
Despite advancements in medical research and treatment protocols over the last few decades, ovarian cancer still poses a significant threat to women’s health. In the United States alone, more than 12,0000 women die of ovarian cancer each year, and only about half of women diagnosed with ovarian cancer survive five or more years past diagnosis. Unlike cervical cancer, there is no routine screening for ovarian cancer, so it often goes undetected until it has reached advanced stages. Additionally, the primary symptoms of ovarian cancer—frequent urination, bloating, loss of appetite, and abdominal pain—can often be mistaken for other non-cancerous conditions, delaying treatment.
An American woman has roughly a one percent chance of developing ovarian cancer throughout her lifetime. However, these odds increase significantly if she has inherited mutations in the BRCA1 or BRCA2 genes. Women who carry these mutations face a 46% lifetime risk for ovarian and breast cancers.
An Unlikely Solution
To address this escalating health concern, the organization Cancer Research UK has invested £600,000 over the next three years in research aimed at creating a vaccine, which would destroy cancerous cells before they have a chance to develop any further.
Researchers at the University of Oxford are at the forefront of this initiative. With funding from Cancer Research UK, scientists will use tissue samples from the ovaries and fallopian tubes of patients currently battling ovarian cancer. Using these samples, University of Oxford scientists will create a vaccine to recognize certain proteins on the surface of ovarian cancer cells known as tumor-associated antigens. The vaccine will then train that person’s immune system to recognize the cancer markers and destroy them.
The next step
Once developed, the vaccine will first be tested in patients with the disease, to see if their ovarian tumors will shrink or disappear. Then, the vaccine will be tested in women with the BRCA1 or BRCA2 mutations as well as women in the general population without genetic mutations, to see whether the vaccine can prevent the cancer altogether.
While the vaccine still has “a long way to go,” according to Professor Ahmed Ahmed, Director of Oxford University’s ovarian cancer cell laboratory, he is “optimistic” about the results.
“We need better strategies to prevent ovarian cancer,” said Ahmed in a press release from the University of Oxford. “Currently, women with BRCA1/2 mutations are offered surgery which prevents cancer but robs them of the chance to have children afterward.
Teaching the immune system to recognize the very early signs of cancer is a tough challenge. But we now have highly sophisticated tools which give us real insights into how the immune system recognizes ovarian cancer. OvarianVax could offer the solution.”