The delay in COVID-19 testing in the United States meant that for weeks
doctors and public health officials were flying blind about who was infected
and the location of major outbreaks. As a result they had little hope
of containing the virus before it started spreading out of control. Why did the US
fall behind almost every other country in this regard? It's a long-standing problem
that's led to needless suffering and loss of life long before the Corona Virus pandemic.
But in this case its impact is so high-profile and far-reaching
that the episode could finally bring lasting reform.
Drastic measures being taken to try to contain the outbreak of a mysterious pneumonia-like virus.
The genetic sequence for COVID-19 was published on January 10th
by Chinese scientists and uploaded to the National Institutes of Health's website
allowing laboratories around the world to create their own diagnostic tests.
German scientists had one within a week, and other countries and private labs quickly followed suit.
The World Health Organization shipped 250,000 of the German version of the tests to labs around the world,
but the US Center for Disease Control decided it needed to rely on its own version of the test,
which would be certified by the Food and Drug Administration, but it wasn't ready until early February.
February 6th and 7th, ninety tests were shipped to state public health labs around the country,
but the kits had a technical flaw and needed to be returned to the CDC for testing.
Meanwhile the virus continued spreading.
On February 4th, the FDA said it would allow government-approved labs
with high complexity testing capabilities to create their own tests,
provided they copy the CDC's approach and send all of their results to the
agency's headquarters in Atlanta for verification. Former FDA Principal Deputy
Commissioner Joshua Sharfstein told the New Yorker you certainly wouldn't want
to say any lab can advertise a coronavirus test because then it's going
to be chaos there's a lot of people who will sell things that may or may not
work though well-intentioned the rule became a stumbling block every virus a
little different but this is one of the more most challenging ones certainly
I've seen in my lifetime take the case of Alex Gruninger a doctor and
researcher at the University of Washington who sent in his application
to create a corona virus test via email according to a report in GQ he then
learned that he also needed to submit a paper copy and then another version
burned to a compact disc or loaded onto a drive and delivered to the FDA's
maryland headquarters after he complied according to
reportin Republica the fda didn't approve his test right away they asked
him to make sure his tests didn't cross diagnosed with SARS and MERS other
coronaviruses which hadn't been seen in the US and years his test was finally
certified on February 29th at which point the fatal outbreak in his
home state of Washington was already underway as the crisis worsened in the
testing shortage drew headlines the FDA simplified the process but then on March
20th they warned that they may shut down efforts to rapidly make available at
home testing kits on the grounds that they were unvetted and could be
fraudulent the first documented cases of joven 19 in the u.s. and South Korea
were discovered around the same time yet as of March 17 one out of 4,300
Americans had been tested in South Korea it's 1 out of 17 had diagnostic tests
for Cova 19 been available sooner they would have helped public health
officials isolate quarantine and provide medical supplies to areas of the u.s.
affected by the virus
how could this happen this tragic testing delay has brought national
attention to the FDA's long-standing overly cautious approach to regulating
American health care to minimize risk the agency is sacrificed speed
preventing doctors and patients from accessing the tools they need until it's
too late the agency's risk reduction over speed of approval goes back to the
1960s when a sleeping pill called thalidomide marketed to pregnant women
cause babies to die in utero or to be born with serious birth defects the
crisis was mostly contained to Europe because concerned FDA regulators have
kept the untested drug out of the u.s. United faith and the best and the most
effective food and drug law of any country in the world in 1962 President
Kennedy signed a landmark bill increasing the agency's oversight powers
it resulted in a culture of extreme caution that led to long approval times
for experimental drugs and devices keeping potentially life-saving tools
out of the hands of patients
the beginning of the movement to relax those roles and rethink the trade-off
between risk and speed in the FDA approval process began during the AIDS
crisis of the 1980s gay rights activists were outraged that the FDA wouldn't
quickly approve more experimental drugs like AZT which blocks HIV replication or
Athol it amide used to treat some of the wasting symptoms of AIDS after lobbying
in protests including the 1988 shutdown of the FDA building the administration
slowly began to loosen its rules leading to the approval of highly active
antiretroviral therapy or Hart in 1996 because of Hart contracting HIV wasn't a
death sentence anymore gay rights activism during the 1980s and
1990s created a framework for patient advocacy to people with life-threatening
illnesses leading to the right to try movement which has allowed terminally
ill patients to access experimental drugs and devices that are still
undergoing FDA testing the movement pushed the agency to streamline its own
compassionate use program to help the same kinds of patients but the Cova 19
testing debacle underscores the limits of those reforms once a full
investigation comes out about the agency's failures perhaps it will bring
fundamental reform at last giving Americans rapid access to potentially
life-saving tools
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