5 Mistakes by the CDC and FDA Set Back Virus Testing
If you don't test, you won't find cases.
After all this time only six US states are testing for the coronavirus.
The following story is based on ProPublica interviews with state and local public health officials and scientists across the country, which, taken together*, describe a frustrating, bewildering bureaucratic process that seemed at odds with the urgency of the growing threat*.
As the highly infectious coronavirus jumped from China to country after country in January and February, the U.S. Centers for Disease Control and Prevention lost valuable weeks that could have been used to track its possible spread in the United States because it insisted upon devising its own test.
The federal agency shunned the World Health Organization test guidelines used by other countries and set out to create a more complicated test of its own that could identify a range of similar viruses. But when it was sent to labs across the country in the first week of February, it didn’t work as expected. The CDC test correctly identified COVID-19, the disease caused by the virus. But in all but a handful of state labs, it falsely flagged the presence of the other viruses in harmless samples.
The CDC announced on Feb. 14 that surveillance testing would begin in five key cities, New York, Chicago, Los Angeles, San Francisco and Seattle. That effort has not yet begun.
The CDC could have authorized the test just for the coronavirus, but no. It wanted everything to work even though everything but the coroinavirus test was useless.
That delay alone added at least 10 days to testing.
The CDC's decision to create its own test added weeks.
“We’re weeks behind because we had this problem,” said Scott Becker, chief executive officer of the Association of Public Health Laboratories, which represents 100 state and local public laboratories. “We’re usually up-front and center and ready.”
On Wednesday, under pressure from health experts and public officials, the CDC and the FDA told labs they no longer had to worry about the portion of the test intended “for the universal detection of SARS-like coronaviruses.” After three weeks of struggle, they could now use the test purely to check for the presence of COVID-19.
Never underestimate bureaucratic stupidity. And the test is still not working.
“Testing for coronavirus is not available yet in New York City,” city Department of Health spokeswoman Stephanie Buhle said in an email late Thursday. “The kits that were sent to us have demonstrated performance issues and cannot be relied upon to provide an accurate result.”
Only 6 States Testing
Until the middle of this week, only the CDC and the six state labs — in Illinois, Idaho, Tennessee, California, Nevada and Nebraska — were testing patients for the virus, according to Peter Kyriacopoulos, APHL’s senior director of public policy. Now, as many more state and local labs are in the process of setting up the testing kits, this capacity is expected to increase rapidly.
Janet Hamilton, senior director of Policy and Science at Council of State and Territorial Epidemiologists, said that with the virus spreading through multiple countries, “now is the time” for widespread surveillance testing.
“The disease,” she said, “is moving faster than the data.”
More CDC Stupidity
Doctors at the University of California, Davis Medical Center, where the patient is being treated, said testing was delayed for nearly a week because the patient didn’t fit restrictive federal criteria, which limits tests only to symptomatic patients who recently traveled to China.
“Upon admission, our team asked public health officials if this case could be COVID-19,” UC Davis said in a statement. UC Davis officials said because neither the California Department of Public Health nor Sacramento County could test for the virus, they asked the CDC to do so. But, the officials said, “since the patient did not fit the existing CDC criteria for COVID-19, a test was not immediately administered.”
Idiocy at the University of Washington Medical Center
Compounding the idiocy at the CDC, the FDA got into the act.
Alexander Greninger, an assistant professor in laboratory medicine at the University of Washington Medical Center, said after he submitted his COVID-19 test, which copies the CDC protocol, to the FDA, a reviewer asked him to prove that his test would not show a positive result for someone infected with the SARS coronavirus or the MERS coronavirus — an almost ridiculous challenge. The SARS virus, which appeared in November 2002, affected 26 countries, disappeared in mid-2003 and hasn’t been seen since.
Don't blame Greninger.
Someone at the FDA was worried about the test showing a positive for the coronavirus when the person really had SARS or MERS.
There are labs that can create parts of a SARS virus, but the FDA’s recommended supplier of such materials said it would need one to two months to provide a sample, Greninger said. He spent two days on the phone making dozens of calls, scrambling to find a lab that would provide what he needed.
Greninger said the FDA was treating labs as if they were trying to make a commercially distributed product. “I think it makes sense to have this regulation,’’ he said, when “you’re going to sell 100,000 widgets across the U.S. That’s not who we are.”
Media Funnel and Censorship
All questions to the CDC and FDA related to the coronavirus must now go through Vice President Mike Pence. But he is not talking.
Pence did not respond to ProPublica questions.
What We Know, and Don't
We do not know who made the decision to design a more complicated test or to depart from the WHO guidance.
We do know there is blatant incompetence at the CDC and FDA, and government censorship of officials.
What's Happening Background
- Feb 19: Fed Minutes Highlight Coronavirus Concerns and Uncertainty 8 Times
- Feb 24: Bond Yields Crash and Gold Soars on Pandemic Threat
- Feb 25: CDC Admits Spread of Coronavirus in the US Appears Inevitable
- Feb 25: Lie of the Day: This is Not a Pandemic
- Feb 25: Nearly 50% Odds of "At Least" 3 Rate Cuts by December
- Feb 26: Trump says We are "Very, Very Ready for the Coronavirus, for Anything"
- Feb 27: Useless Act: California Monitors 8,400 People for Coronavirus; 33 Test Positive
- Feb 27: Containment Fails: Coronavirus Tweets of the Day
- Feb 27: Tweets of the Day: Iran's VP Infected, Japan Closes All Schools
Please recall on Wednesday evening President Trump addressed the nation stating "We are Very, Very Ready for the Coronavirus, for Anything".
What an amazing lie.
Here's the question of the day: When do we rename the FDA the Federal Death Agency?
Mike "Mish" Shedlock