LyrArc Article Gist
Analysis of its findings in the WSJ story on August 18 shows the FDA unnecessarily delayed private labs from developing and using their own tests from Feb 9 when FDA test for coronavirus failed for its third component. The FDA said it would correct the flaws but repeatedly failed to do so until it finally allowed private labs to go ahead on their own- a costly delay of 3 weeks that made the test and contact trace strategy inoperable, because the time window was lost in those 3 critical weeks. In March through August the pandemic has now taken up about 5 million cases in the U.S. and 170,000 deaths, with no end in sight. During times like these and in a swiftly moving current of a river such as the time of a pandemic, the  teaching hospital labs and labs with resources and scientific reputation with their lightning speed have to have the freedom  to immediately respond. In this case the FDA should have released the private labs of teaching hospitals and the the highly reputable labs of well known medical companies to immediately start developing their own tests and using them, starting  on Feb. 10 the day after it was evident that the FDA test's third component was not working. ...

LyrArc Article Gist
This important WSJ report shows how the CDC labs failed to come with the test after contamination of a component and failure of the third part of the three part test components. In the absence of a working test from CDC where delays cost three weeks of February the private labs all over the country and state labs could have developed their own test, yet HHS and FDA required approval for these labs to develop their own test and use it. From Feb. 8 when state and city public health labs detected problems with the CDC test to Feb 29 when solutions were developed including simply excluding the third part of the three component test, and letting labs around the country do their own test, were 3 crucial weeks that let the virus spread out of control. The CDC, HHHS, and the FDA and their managers and heads of departments bear responsibility for these errors. Week after week the delays continued, instead the two component test which detects if the genetic material in the sample is coronavirus material, could simply have been approved at the outset instead of the approval for this given weeks later. The third component of the test checks if the virus mutated, according to this report. There is no explanation why the labs all over the U.S. were not allowed to go ahead on February 9 itself or within a few days after that to develop their own tests once it was clear the CDC test did not work on that day. CDC officials failed to recognize that there was a possibility that they may not be able to fix the faulty third component of the test and the risks if they gave false reassurances. There is also no explanation of why a German designed test was not used once the CDC test failed on Feb. 9, which would be a proper way for action considering that this pandemic had already shutdown parts of China by this time. Alarming also is the mention in this report that on Feb. 22 a FDA official in charge of lab diagnostics  flies to Atlanta where the CDC Respiratory Diagnostic lab which developed the test is located. His boss FDA medical device center director is cited from later information as describing the lab as "filthy" meaning the lab had the potential to contaminate, and going so far as saying that if it had been any other lab it would have been shut down. Considering that investment in public health has deteriorated over the last two decades and that there has been a massive misallocation of capital in the country away from public infrastructure this is appalling. The thought of critical labs for emergency health needs as not being up to high quality standards in the U.S. as a result of two decades of misspending, that this shows, is very disturbing.  This WSJ report is based on interviews with people who know about the testing crisis, and undisclosed emails, correspondence on the issues involved. Community transmission began in January 2020 in the U.S. These delays were costly in February and could have been prevented either by going with the German design on Feb 10 or asking labs across the U.S. to develop their own test, and letting other labs immediately use the modified 2 component test of CDC that worked instead of doing this action weeks later. Mardi Gras on Feb 25 and other places where large crowds gathered in sports stadiums could have been stopped had testing gone forward and shown the true extent of the community transmission in these critical weeks.  First China delayed a U.S. team of experts coming into the country for weeks, and then the CDC, FDA, HHS, failed to get testing started, creating  a false sense of complacency. Two crucial errors outside and inside the country that caused so much damage to America and the world.   ...