The U.S. has failed to effectively implement widespread testing for COVID-19, allowing rates of infection to climb and extended stay-at-home orders to persist. Other countries, such as South Korea and Singapore, responded with aggressive testing early on, minimizing further spread and suppressing transmission of the virus without widespread shutdowns.
Mike Ryan, head of the World Health Organization’s Health Emergencies Programme, told NPR, “We've seen examples in places like Singapore and [South] Korea, where governments haven't had to shut everything down. They've been able to make tactical decisions regarding schools, tactical decisions regarding movements, and been able to move forward without some of the draconian measures."1
What happened in the U.S. to prevent COVID-19 testing may go down as one of the greatest debacles in history, triggered by bureaucratic red tape.
FDA Regulatory Barriers Delayed Widespread Testing in the US
In January 2020, German scientists developed the first diagnostic test for COVID-19. In early February 2020, WHO shipped about 250,000 tests to 159 laboratories around the world.2 As noted by South Korea's foreign minister, Kang Kyung-wha, “Testing is central” to outbreak responses, as it “leads to early detection” and helps minimize spread, as those who test positive can be isolated.
Rather than use the WHO test, the U.S., under the direction of the CDC and FDA, decided to create its own, as it had done with tests during past outbreaks of Ebola and Zika. CDC adviser William Schaffner, told Business Insider:3
"The notion of accepting a test developed by someone else I think was a bit alien. There may have been other considerations of which I'm not aware, but I'm sure that pride was one of them: 'We know how to do this, thank you very much. We'll develop our own.'"
On February 4, the U.S. FDA approved the U.S. COVID-19 test, and the CDC shipped 90 of them to state public health labs days later. According to Business Insider, “By that point, the U.S. had only confirmed about a dozen coronavirus cases, including two cases of person-to-person transmission.”4
The New York Times summed up U.S. testing failures as “the lost month” — a time between late January and early March 2020 during which widespread testing may have changed the course of the pandemic in the U.S.:5
“[L]arge-scale testing of people who might have been infected did not happen — because of technical flaws, regulatory hurdles, business-as-usual bureaucracies and lack of leadership at multiple levels, according to interviews with more than 50 current and former public health officials, administration officials, senior scientists and company executives.
The result was a lost month, when the world’s richest country — armed with some of the most highly trained scientists and infectious disease specialists — squandered its best chance of containing the virus’s spread. Instead, Americans were left largely blind to the scale of a looming public health catastrophe.”
‘Unprecedented’ Testing Glitch Causes Testing Delays
After the initial test rollout, an “unprecedented” problem with a test ingredient caused inconclusive results in many of the tests. While the CDC manufactured new tests, labs had to send samples to the CDC for testing, which led to delays of up to 48 hours.6
Experts, including Christian Drosten, a researcher at the German Center for Infection Research, told Business Insider that multiple tests should be developed so that there’s a backup if a problem occurs with one of the tests. According to Drosten:7
"If we are in doubt about our test, or if there is something wrong with the test targets, the virus mutates or something, we could still switch to the test that another lab uses. These are all in the public domain, and it's quite easy to switch.”
What’s more, initially, the CDC only recommended testing people with symptoms and a history of travel to China or contact with a coronavirus (lab-confirmed) patient. “That meant the country's first case involving community spread, a patient in California, went untested for multiple days at two hospitals,” Business Insider noted.
It wasn’t until February 27 that the CDC testing criteria was revised to include hospitalized patients, but those with mild symptoms still did not get immediate testing.
In contrast, in Hong Kong and Singapore, testing occurred swiftly not only for hospitalized patients but also people with mild symptoms or suspected cases. Tens of thousands of people who were potentially exposed to those who tested positive were then quarantined, the vast majority being healthy people who ended up not getting sick.
“Tedros of the WHO refers to this as cutting off the virus at the bud — basically stopping the virus from spreading further and preventing community transmission,” according to NPR.8 In late February, the FDA began allowing laboratories certified to perform high-complexity testing to develop their own COVID-19 tests, but by March there still weren’t enough available tests to keep up with demand.
During the first week of March 2020, the U.S. had conducted an estimated 18 tests per million people, while South Korea had conducted 3,692 per million. By March 20, the U.S. continued to lag behind, having tested only 313.6 people per million, compared to 6,148 per million in South Korea, 12,738 per million in the United Arab Emirates and 26,772.3 per million in Iceland.9
As more cases spread among communities, there remained strict criteria of who could receive a test. Schaffner continued in March:10
"I still hear that the states have a criteria that you have to meet before your specimen can be accepted for testing, so doctors and other healthcare providers have to call the state health department. There may be a wait because there are a number of people who are calling in trying to get testing and figuring out how to get it done. That still is a bit cumbersome.”
FDA’s Role in Slowing the Testing Process
Other hurdles also stood in the way of widespread testing in the U.S. While laboratory developed tests typically do not require FDA pre-approval, the declared public health emergency triggered rules that required labs to receive an Emergency Use Authorization (EUA) from the FDA in order to roll out tests for COVID-19.
As mentioned, this meant labs weren’t allowed to develop tests until late February. The Alliance for Natural Health USA (ANH USA) reported:11
“According to former FDA officials, in previous outbreaks EUAs could be obtained in a matter of days; but during this outbreak, the application process reportedly became so complicated it took weeks to receive the authorization. Initially, labs were not allowed to begin testing until they got approval from the FDA, even if the lab had confirmed internally that the test worked.
The FDA later relaxed this requirement, allowing certain accredited labs to begin testing as they awaited approval for an EUA — but not before weeks had passed when hospitals and labs were not able to use accessible COVID-19 tests.”
Some labs even developed at-home tests for COVID-19, but the FDA said it had not approved any at-home tests, leading companies to pause distribution and even destroy samples that had already been collected. South Korea, which has been producing 400,000 COVID-19 tests per week, has also been shipping the tests to U.S. states and private labs, but gaining FDA approval on the tests remains a significant hurdle.
There are two types of tests now available in the U.S. — one, known as the polymerase chain reaction test, which uses a nasopharyngeal swab, and the other, a serological test that uses blood samples to detect COVID-19 antibodies.
U.S. testing capacity has increased, but still lags behind most other developed countries. As of April 5, 2020, the U.S. had conducted 5,316.43 tests per million people, compared to 9,062.93 in South Korea and 81,228.8 per million in Iceland.12
Backlogs at laboratories are also creating bottlenecks. According to Vox, “As of April 6, Quest Diagnostics, one of the largest private testing facilities in the U.S., still had a backlog of roughly 80,000 tests as it faces more demand than it can handle.
Adjusted for population, the U.S. has tested at just 74 percent the rate of South Korea — where widespread testing has been credited with containing the country’s outbreak — and is even further behind Germany, Italy and Canada.”13 According to the Alliance for Natural Health USA, in a letter to Congress calling for the FDA to stop blocking access to COVID-19 testing, it’s noted:14
“The FDA's slow response time and its insistence on enforcing mindless bureaucracy is indefensible and has made this pandemic worse …
While we certainly do not want to open the door for fraudulent tests that do not give reliable results, companies should be allowed to innovate and create solutions where the federal government has failed so miserably at nearly every turn to meet the demand for tests during this pandemic.”
Widespread Testing Needed to End Social Distancing
With much of the U.S. still under stay-at-home orders and practicing social distancing, it’s revealing that in some countries where aggressive testing was successful in helping to contain the outbreak, widespread shutdowns have not occurred. In South Korea, Hong Kong and Singapore, for instance, most restaurants, shopping malls and factories have remained open.
In Singapore, schools have also stayed open, with Singapore's minister of education, Ong Ye Kung, stating, “… evidence [is scarce] to show that the young are vectors or spreaders of the virus. The reverse appears to be the case, where the young get infected by adults at home."15
While the way COVID-19 spreads is still being explored, experts agree that widespread testing is needed for the U.S. to reopen its economy and get back to a sense of normalcy.
Speaking with Vox, Dr. Krutika Kuppalli, a fellow in the Johns Hopkins Center for Health Security Emerging Leaders in Biosecurity program, said, “It’s one of those things that is absolutely astounding. Three and a half months into this outbreak, we’re still talking about the basic issue of we need to get testing up and going.”16
Multiple hurdles still stand in the way of COVID-19 testing, from lack of supplies like swabs and machines needed to run the tests, to labs losing revenue as fewer elective tests are being performed, yet being expected to ramp up COVID-19 tests, which have low reimbursement rates.
Current COVID-19 tests may also not be sensitive enough and could lead to false negatives, while the U.S. also lacks reliable tests to check people for COVID-19 immunity.17 In order to reopen society, access to rapid testing will be necessary so any cases that pop up can be quickly identified and contained. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, told Vox:18
“You want to make sure that whatever cases that do occur after social distancing occur at a slow enough clip that it doesn’t overwhelm hospital capacity. It’s not a question of whether there’s going to be more cases after you lift social distancing. They are going to occur. We just want them to occur at a rate that is manageable. And the only way that’s going to happen is with testing.”
If you’d like to share a message with your senators, representative and the FDA urging them to remove barriers to COVID-19 testing, you can use ANH USA’s letter, which highlights the need for widespread testing and an FDA overhaul to protect Americans’ health and safety.19
Source: mercola rss