The Federal Dipshitment And COVID-19 Testing
From March 11 (but I just saw it), a Seattle lab uncovered Washington's coronavirus outbreak only after defying federal regulators and running tests for it, writes Peter Weber in The Week:
A lack of test kits for the new COVID-19 coronavirus is still obscuring the extent of the outbreak in the U.S., but for a critical period in February, there were no functional federal tests and "local officials across the country were left to work blindly as the crisis grew undetected and exponentially," The New York Times reports. The coronavirus has now infected more than 1,000 people in 36 states and Washington, D.C., according to Johns Hopkins University's count.The first U.S. outbreak was in Washington state, where authorities confirmed the first patient -- suffering from respiratory problems after visiting Wuhan, China -- only after the Centers for Disease Control and Prevention made an exception to strict testing criteria. In Seattle, Dr. Helen Chu, an infectious disease expert who was part of an ongoing flu-monitoring effort, the Seattle Flu Study, asked permission to test their trove of collected flu swabs for coronavirus.
State health officials joined Chu in asking the CDC and Food and Drug Administration to waive privacy rules and allow clinical tests in a research lab, citing the threat of significant loss of life. The CDC and FDA said no. "We felt like we were sitting, waiting for the pandemic to emerge," Chu told the Times. "We could help. We couldn't do anything."
They held off for a couple of weeks, but on Feb. 25, Chu and her colleagues "began performing coronavirus tests, without government approval," the Times reports. They found a positive case pretty quickly, and after discussing the ethics, they told state health officials, who confirmed the next day that a teenager who hadn't traveled abroad had COVID-19 -- and the virus had likely been spreading undetected throughout the Seattle area for weeks. Later that day, the CDC and FDA told Chu and her colleagues to stop testing, then partially relented, and the lab found several more cases. On Monday night, they were ordered to stop testing again.
Yes, ignore viruses and they will slink away, feeling terribly snubbed, and the world will be as it was again.
Right?
Meanwhile, burial pits from Iran's coronavirus outbreak have grown so large you can see them from space.
And what difference does testing make?
Here's something that's absolutely terrifying: a comparison of the age distributions of Covid-19 cases in Italy, where they are only testing people who show symptoms, and S. Korea, which has broad testing. A whole lot of 20-29yos out there who feel just fine but are v contagious. pic.twitter.com/BU96h3VKUc
— Mark Byrne (@markwby) March 14, 2020
Here's how it's going in China -- where you get your temperature taken when you enter a building:
this guy rules
— rat king (@MikeIsaac) March 13, 2020
pic.twitter.com/67pId4kC4i
The first U.S. outbreak was in Washington state, where authorities confirmed the first patient... only after the Centers for Disease Control and Prevention made an exception to strict testing criteria.
Not right. The first case in Washington was confirmed by the CDC on January 20. The patient returned from Wuhan, China on January 15th. He went to an urgent care clinic in Snohomish County with symptoms on January 19th. The clinician notified local and state health departments. The clinician and Washington State Department of Health notified the CDC. Lab test samples were collected. The patient was discharged to home. The positive test result was confirmed by the CDC on January 20th.
More than a month later ...on Feb. 25, Chu and her colleagues "began performing coronavirus tests, without government approval," the Times reports.
I don't know why not just anyone capable of testing for a disease is allowed to do so. Having worked in both healthcare and clinical research I can say that what doctors and nurses are allowed to do when they work as researchers is different than what they're allowed to do when they work as healthcare practitioners. I've read that because they're researchers and not medical practitioners, Dr. Chu and her colleagues aren't qualified to diagnose and treat illnesses. Nonsense. They're as qualified as any other doctors. They're just not allowed.
Ken R at March 15, 2020 1:06 AM
I don't know why not just anyone capable of testing for a disease is allowed to do so. Having worked in both healthcare and clinical research I can say that what doctors and nurses are allowed to do when they work as researchers is different than what they're allowed to do when they work as healthcare practitioners. I've read that because they're researchers and not medical practitioners, Dr. Chu and her colleagues aren't qualified to diagnose and treat illnesses. Nonsense. They're as qualified as any other doctors. They're just not allowed.
Ken R at March 15, 2020 1:06 AM
You seem to have a lot more confidence in the ability of just anyone to develop and administer a reliable test than I do. It isn’t that simple from what I have read.
Wish I could find the article, I was pretty sure that in the Wall Street Journal I read that South Korea was using three or four different and sequential tests to confirm the virus and confirm a post virus non infectious state.
Isab at March 15, 2020 5:39 AM
The ability to administer the test isn't that difficult Isab. But the tests aren't that reliable yet. Brand X may not pick your particular infection up while the slightly different Brand Y does. Or vice versa. And then there are the false positives where you aren't infected but Brand Z insists you are.
As to why researchers aren't allowed to do the same things medical personnel are allowed to do? That is just how the law grew. It is about credentials and liability. You may be able to design and even build a perfectly functional bridge. But if you aren't a PE then don't do it. Same with these test kits. The ones the CDC put together didn't really work. Private companies put functional ones together but they weren't willing to distribute them until they had FDA approval. Too big of a liability issue. If someone decides to sue Dr Chu they have a good chance of winning.
Ben at March 15, 2020 7:16 AM
Remember, the virus is faster than the CDC, FDA and WHO combined. And the WHO is busy sucking up to the ChiComs.
If someone decides to sue Dr Chu they have a good chance of winning.
The wording of the quoted section suggests that it is at least a HIPPA violation, which carries significant civil penalties.
I R A Darth Aggie at March 15, 2020 1:08 PM
"Dipshitment" is a wonderful coinage.
Crid at March 15, 2020 4:40 PM
If someone decides to sue Dr Chu they have a good chance of winning. -Ben
The wording of the quoted section suggests that it is at least a HIPPA violation, which carries significant civil penalties. -IRA
You seem to have a lot more confidence in the ability of just anyone to develop and administer a reliable test than I do. -Isab
What do you think they'd be sued for? Any study subject who doesn't want to know a test result can decline. Any subject can withdraw from the study any time they want to. There's no risk or harm to them, only advantage. The clinicians running the Seattle Flu Study don't diagnose or treat any illness, though they have more than enough expertise to do so. The COVID-19 test they use is most likely very accurate and reliable (if it's not their study data won't be valid) but probably not FDA approved (I don't know). Subjects informed of positive test results are advised to consult a healthcare provider.
There's no HIPPA violation. For any disclosure of information the Seattle Flu Study, like any other study, would have the informed consent of subjects, the approval of one or more institutional review boards, and would stay meticulously within the parameters of the study protocol, since not doing so could invalidate the study results or cause the IRB to stop the study. In the case of the Seattle Flu Study, the IRB and local and state public health authorities have decided it would be unethical for them not to test for COVID-19. They have the authority to to do that whether the CDC agrees or not. Other than the disclosures specified in informed consent documents, Dr. Chu has said that the only person notified of a test result is the person tested.
As far as "confidence in the ability of just anyone to develop and administer a reliable test", the PCR tests used to test for coronavirus and a bazillion other things have been around for decades, are accurate, simple and common, and inexpensive.
The automated tests they use in South Korea were developed and manufactured by at least four different private companies and are used in more than a hundred private labs. Unlike the US, the South Korean government got out of their way and let them do what they do. The automated tests, not being limited by human speed and fallibility, are fast and accurate. A company in Canada also has an automated PCR test for COVID-19 ready to market. It'll take time to tool up and manufacture it, probably more time for the FDA to OK it, and even more time for the CDC - which seems to want to limit COVID-19 testing to its own FDA-approved-on-February-20th rRT-PCR test - to authorize its use.
Ken R at March 15, 2020 5:01 PM
This would be interesting:
Crid at March 15, 2020 7:15 PM
I think Chu could be sued for publishing her results. As you point out Ken she didn't have authorization to do that. Plenty of city or state DAs could take her to court over that.
Now, do I think it should be that way, no. I agree with you Ken. Just acknowledging the law isn't perfect and she took a risk doing what she did.
Ben at March 16, 2020 8:32 AM
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