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ANNEX – FDA – CDC – TESTS (Business Review)
Government officials should have moved much more
quickly to bring on expertise from outside the CDC.
At the beginning, U.S. efforts to develop a diagnostic
test for the corona virus kept pace with the rest of the world.
Shortly after publication of the virus’s genome in
early January, German researchers announced they had designed a diagnostic test. Then, within days,
scientists at the CDC said they’d developed one, too, and even used it detect the first U.S. case.
From there, however, U.S. efforts fell quickly behind,
especially when compared with the efforts of the WHO, which has distributed
more than 1 million tests to countries around the world based in part on the
method developed by the German researchers.
As early as Feb. 6, four weeks
after the genome of the virus was published, the WHO had shipped 250,000
diagnostic tests to 70 laboratories around the world, the agency said.
By comparison, the CDC at that time was shipping about
160,000 tests to labs across the nation — but then the manufacturing troubles
were discovered, and most would be deemed unusable because they produced
confusing results. Over the next three weeks, only about 200 of those tests
sent to labs would be used, according to CDC statistics.
The U.S. efforts to distribute a working test stalled until Feb. 28, when federal officials revised the
CDC test and began loosening up FDA
rules that had limited those who could develop corona
virus diagnostic tests.
During that critical interval, the CDC repeatedly
assured the public that progress was being made, even as public health
officials around the country began to raise alarms about the shortage of tests.
On Feb. 21, Messonnier acknowledged problems with the
testing kits, but described the issues as “normal.”
But by that point, public health labs around the nation had run very few
of the CDC tests, according to the agency. Health officials across the country
began pleading for a test that worked, or at least the authorization to use
another test.
Finally the FDA relaxed its testing rules on Feb 29.
Many of the state public health labs had also figured
out how to use the CDC test properly — by tossing one of its components — but
were not allowed to actually do so until the FDA approved the work
“We had all these state public health labs that had a
perfectly good [test] on their hands, and they knew it, they were upset,”
Greninger said.
Thomas Frieden, an infectious disease physician who
served as CDC director under former president Barack Obama, called on Sunday
for an “independent group” to investigate what went wrong with the CDC’s
testing process. He said that in the past, the CDC moved quickly to produce
tests for diseases such as H1N1, or swine flu.
“We were able to get test kits out fast,” Frieden said
on CNN. “Something went wrong here. We have to find out why so we can prevent
that in the future.”
Frieden said the agency has been somewhat muzzled
under President Trump.
THE END
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