5 Mistakes by the CDC and FDA Set Back Virus Testing

Mish

The CDC designed a flawed test for COVID-19, then took weeks to figure out a fix. The FDA made additional errors.

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*.

Please consider Key Missteps at the CDC Have Set Back Its Ability to Detect the Potential Spread of Coronavirus

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.

FDA Idiocy

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

  1. Feb 19: Fed Minutes Highlight Coronavirus Concerns and Uncertainty 8 Times
  2. Feb 24: Bond Yields Crash and Gold Soars on Pandemic Threat
  3. Feb 25: CDC Admits Spread of Coronavirus in the US Appears Inevitable
  4. Feb 25: Lie of the Day: This is Not a Pandemic
  5. Feb 25: Nearly 50% Odds of "At Least" 3 Rate Cuts by December
  6. Feb 26: Trump says We are "Very, Very Ready for the Coronavirus, for Anything"
  7. Feb 27: Useless Act: California Monitors 8,400 People for Coronavirus; 33 Test Positive
  8. Feb 27: Containment Fails: Coronavirus Tweets of the Day
  9. 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

Comments (91)
Sechel
Sechel

The WH official charged with leading the US response to deadly pandemics left nearly two years ago as his global health security team was disbanded. Federal funding for preventing the spread of infectious disease has been threatened since Trump's election. .

No. 1-25
KidHorn
KidHorn

This isn't a Trump thing. Although Trump doesn't help. This is a government thing. Do you really expect a bunch of career bureaucrats to quickly come up with a good logical solution to a new problem? They're trained to be politicians. Not scientists.

Stuki
Stuki

Not to excuse bureaucratic clumsiness, but the backdrop for this, is that "tests" currently in use around the world, aren't paragons of reliability. It's not a matter of "good" tests laying around, while the CDC decided to, pick the bad ones. Instead, it's a bit of a hit-and-miss, evolving field on all counts.

The optimal course of action, would be to ask the Chinese for help. They are far and away the ones with the most real world experience at this by now. Their tests are, or at least have been thoughout the outbreak, a bit hit and miss as well, but that ambiguity just makes it even more beneficial to have people with broader real world experience, help interpreting and administering them.

Fat chance an administration, bureaucracy and sycophant army of well indoctrinated dronelings firmly dug into a-priori positions about the Chinese "mishandling" everything, doing so, though.

tokidoki
tokidoki

That's why we are better than China .... NOT!!!!

We don't need censors, when we have this level of incompetence. Also, where are the vaunted market players? Mask prices are through the roof, so there should be companies making masks now right, right?

Instead, according to Reuters, the government is considering invoking the Defense Production Act to rapidly expand domestic manufacturing of protective masks and clothing to combat the coronavirus in the United States, two U.S. officials told Reuters.

This coronavirus makes fun of both governments and the "market". ROFL. FUN, FUN, FUN.

abend237-04
abend237-04

What the CDC tried to do with too little, too late should have been started on a Manhattan project scale in 2003, when SARS made it blatantly apparent that the world had no early detection and warning system for coronaviruses, five of the seven now known to exist have been discovered since the turn of the century.

Thus far, none of them have appeared to give a damn who's in the White House.

If this additional unearned opportunity to get our act together degenerates into just another election year gong show and cat fight, our tsetse fly attention spans may kill us all yet.

We still had none when Ebola hit 11 years later in Africa.
It's not a Trump problem; it's our tsetse fly attention span problem.

awc13
awc13

"After all this time only six US states are testing for the coronavirus."

bingo. My state legislators and the governor (oregon) are focused on getting a CO2 cap and tax program passed. they are seemingly completely oblivious to this avalanche coming down the mountain

njbr
njbr

But hey, in the all important pre-outbreak PR phase of the coronavirus fight, the leader of the fight has important business in Florida--speech to a conservative group this morning and a fundraiser this afternoon.

Hope the actual worker-bees know how to get him on the phone if there were an actual crisis he had to respond to. Because it is clear that nothing can happen without approval from the top.

awc13
awc13

on the bright side it appears that china has stopped the spread.........

awc13
awc13

the experts on the news last night said that plans to use stadiums/sporting arenas to house the sick were ridiculous that it is better for people to stay at home when sick.

i thought to myself, what about those who are living on the streets?

Iowan
Iowan

You never know how bad the incompetence gets in the "easy" times unfortunately. Even Lincoln had to weed out the career appointed buddy-buddy losers during the Civil War.

njbr
njbr

The problem that China has right now is that a portion of people recovered from the illness still carry the virus and can infect others.

How would China allow free-travel to people who can infect others? It would just allow the fire to start all over again in a new population.

Sounds like this would be a long-term damper on the economy.

thimk
thimk

Great find, i was nibbling around the periphery and could not find any info on the status of testing . Seems that much material might be censored . CDC decides to reinvent the wheel when a rapidly expanding infection is knocking at our doorsteps.
Why didn't the CDC clone/review/implement/adopt testing methodology other countries are using , which seem to be vary effective (Particularity Singapore ).
Rush L had Corona Czar Pence on show today to speak of the virus . He said virtually nothing talking in generalizations and heralded trump's quick response .

Casual_Observer
Casual_Observer

We are as ready as any other country is what Trump really meant. This is true because most medical research still happens in the United States. Of course the maybe the world hasn't seen anything like this before but just because you are ready doesn't mean anything. It is like being a vegetarian and expecting not to get eaten by animals.

SMF
SMF

Never underestimate the capacity of a bureaucracy to slow down anything it touches.

RayLopez
RayLopez

China numbers don't add up, unless you do some funny 'weighted averages' with demographics that I'm not privy too. See story below.

Also note Friday's new numbers in China are 329 over the last 24 hours, the "lowest in a month" with 329 new cases, but notice on 2/18, about ten days ago, we also had almost the same "low daily new case number" and it jumped up in the subsequent days. Time will tell if the same thing happens now. See chart here: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

Note crude death rate: 2.8/82 = 3.4%

RayLopez

A recent study from the Chinese Center for Disease Control and Prevention (CDC) analyzing 72,314 coronavirus cases in mainland China found that while about 80 percent of cases are mild, the virus poses the greatest threat to elderly people with preexisting health issues.

The research shows patients older than the age of 80 had a 14.9 percent chance of dying after being infected, while those in their 70s were found to have an 8 percent chance of death. Patients in their 50s were about three times more likely to die than patients in their 40s, at a rate of 1.3 percent.

Patients ages 10 to 19 were as likely to die as patients in their 30s, at just 0.2 percent. The study did not report any deaths in children younger than 10, who represented less than 1 percent of patients.

The study collected data from confirmed patients through Feb. 11 and is one of the largest such samples in a study of its kind.

The risk of dying dramatically increased among patients in their 70s and 80s as many in this age group are more likely to have preexisting health conditions.

Coronavirus patients with heart disease had a 10 percent mortality rate, while those with diabetes had around a 7 percent mortality rate.

Men were also found to have a 2.8 percent fatality rate, versus 1.7 percent for women, according to the study. The overall fatality rate in China was 2.3 percent.

Scientists say there are a number of factors that could be contributing to why men are more vulnerable in the current epidemic. Some are biological — for example, women have a stronger immune response to viral infections particularly of the respiratory tract — and some are rooted in lifestyle, The New York Times reports. In China, for instance, men smoke in much greater numbers than women.

The World Health Organization (WHO) said Friday people aged 60 and older and have an underlying condition like cardiovascular disease, respiratory condition and diabetes have a risk of developing severe COVID-19. WHO recommended these people avoid crowded areas or places where they might interact with people who are sick.

WHO reported Friday there are more than 82,000 cases worldwide, with more than 2,800 deaths. The majority of cases occurred in China, where the outbreak originated. Health officials said Friday China reported 329 new cases in the past 24 hours, the lowest in over a month.

Six000mileyear
Six000mileyear

The fastest, most effective action to take was to quarantine the US. Halt all flights. Cruise ships would have to go remain offshore with the merchant marine delivering fresh food and supplies. Too many elected officials were thinking with their campaign contributors' donations instead of the lives they were sworn to protect.

tokidoki
tokidoki

New case reported in Santa Clara. Another "community" transmission. The sharing economy is going well.

thimk
thimk

@thimk Oh and why is the CDC controlling the distribution of testing material with their own "branded" packaging ? we need a reliable test and we need it now. every medical institution; clinic et al should have one on its shelves .

Carl_R
Carl_R

No more worries. We're safe now. Pence has chosen his three key assistants, two of which are Larry Kudlow, and Steve Mnuchin. With their expertise and experience in pandemic containment, we are in good hands.
/sarc

Stuki
Stuki

A central pillar of fully financialized retardtopias, is the indoctrination of their captive dronelings into the belief that those who have received unusually large welfare checks from The Fed, did so because they are somehow “smarter” than the average homeless guy. In the jargon, it’s referred to as legitimizing privilege.

Now, since the indoctrination effort appears to have largely been successful, dunces of all stripes no doubt walk around believing Mnuchin and Kudlow are somehow “smart”, or “good at” something. Aside from collecting welfare, even. Hence, they are someone “we” should listen to.

dodo
dodo

"If you don't test, you won't find cases." IMHO that reflects very much what the US and some other countries with low Corvid cases are doing.

Maybe you folks are learning fast from the chinese, koreans, italians and japanese: why test and be exposed to all sorts of worldwide scrutiny and widespread panic when you can give excuse that the test kits arent perfectly ready yet?

Its quite telling when a country under the current circumstances are delaying testing because people are worried that these tests, fully capable of detecting Corvid19, arent able to prove they are not flagging out SARS or MERS instead. Folks just dont want to look bad with more cases than some third world country. At the end, whether a patient has SARS, MERS or Corvid19, wouldnt you want to know immediately and isolate the patient from society?

numike
numike

Trump says he can bring in coronavirus experts quickly. The experts say it is not that simple. WaPo. All the way at the end:

It is not easy to persuade a lot of people with specialized skills to suddenly shift to federal service to help respond to a threat, said Shahpar, who now works at Resolve to Save Lives, a global nonprofit that aims to prevent epidemics and deaths from cardiovascular disease.

“They have stable jobs with retirement plans,” he said. “They are not going to quit their job at the university or quit their job in the local government to go join the U.S. federal government for six months because of coronavirus. It doesn’t work like that.”
Carl_R
Carl_R

If you look at the worldometers chart of cases outside of China, and switch to the log chart, you can see that the line has turned upwards. It took 20 days to get from 100 to 1,000 cases. It appears that it will take 13 days to get from 1,000 to 10,000, and based on the rate the last few days it will take only 10 days to get from 10,000 to 100,000. That would put us at 10m cases outside of China by the end of March.

The US currently accounts for 1.2% of the cases outside of China, and if that remains constant, that would mean about 120,000 cases in the US by the end of March. Now, with a 5% critical rate, that means 6,100 people in critical condition. If the death rate is 1%, it would mean 1,100 deaths by the end of March. If that growth continued through April, the US healthcare system would break by the middle of April.

Based on the slower spread of Coronavirus in tropical regions, there is reason to believe that the rate will soon slow down. In the US, the flu season typically peaks from December to February, but can run as late as May. Thus, the above projections are unlikely to happen. More likely we will end up closer to 60k cases in the US by the end of March and 100k by the end of April. However, that is more than enough seeded cases to assure that when it starts spreading again in the Fall, it could be really bad if there is no vaccine.

Anyone that believes that the US has it completely contained should obviously wonder why we saw new cases of community transmission in California, Oregon, and Washington state in the last day or so. We'll see more soon, unfortunately.

tokidoki
tokidoki

First American death in the state of Washington. I suggest we update the definition of Caucasian to exclude Americans and Italians. That will keep number of Caucasian death to zero. Thoughts?

Sechel
Sechel

Seems like a cruel joke to expect the person who claims Corona is a Democratic hoax to be able to head up an effort to stop it


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