"To repurpose the tests for monitoring the coronavirus, they would need the support of state and federal officials. But nearly everywhere Dr. Chu turned, officials repeatedly rejected the idea, interviews and emails show, even as weeks crawled by and outbreaks emerged in countries outside of China, where the infection began. By Feb. 25, Dr. Chu and her colleagues could not bear to wait any longer. They began performing coronavirus tests, without government approval. What came back confirmed their worst fear. They quickly had a positive test from a local teenager with no recent travel history. The coronavirus had already established itself on American soil without anybody realizing it. 'It must have been here this entire time,' Dr. Chu recalled thinking with dread. 'It’s just everywhere already.'... Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether...."
From "'It’s Just Everywhere Already': How Delays in Testing Set Back the U.S. Coronavirus Response/A series of missed chances by the federal government to ensure more widespread testing came during the early days of the outbreak, when containment would have been easier" (NYT).
Coronavirus makes medical ethics look like red tape.
I found that article as I was looking for something about the true number of coronavirus cases in the U.S. I see that, right now, there have been 1,039 cases confirmed in the United States, but, as the linked article makes clear, the testing for the virus has been quite limited.
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Election optics overrule truth. That covers politicians and the media. The rest of us get stuck with the bill- both financially and biologically.
Apparently good info garnered and stored in one place:
https://www.worldometers.info/coronavirus/
(NYT)
Eh.
If the tests expand exponentially at a higher rate than the virus, eventually the tests catch up.
Anyone know the rate of false positives for us tests? My understanding is that it is pretty high but I could not find a number just now.
If it is high, if a lot of people without flu test positive for it, it seems like widespread testing might be more dangerous than not testing.
A person falsely diagnosed might be quarantined with people who do have it an might get it.
Non-sick people would overload favilities and resources.
Excess numbers, with help from media, would create even wider panic.
John Henry
If it is already everywhere that means it is nothing more then a serious strain but not ridiculously so. It would make the percentage of fatalities more in line with standard flu.
There are a LOT of rules surrounding human testing, lab testing, patient privacy, etc, etc.
Honestly, they will probably get in a boatload of trouble for doing that testing. I'm not dis/approving, just pointing out that this is the regulatory world we've built in education, healthcare, government, and business.
-XC
Cuomo just activated the New York national guard and them to New Rochelle. My guess is we are at several hundred thousands of infected with little to no symptomology.
There is more and more government regulation of American life. It is usually justified on the grounds that it is necessary to keep us safe. And that is some times true. But regulators too often succumb to the notion that their permission should be required to do anything in their field of regulation. That can lead to making people less safe.
Medical ethics is bureaucratic decision making. Bright line rules applied in changed circumstances often do not make sense. How many movies are based on the premise that the good guy must break rules to achieve justice?
And here there are real humans at risk for early death. So the calculus is no longer so clear as when the bureaucrats first got involved.
Go to worldometers.info. I have been plotting USA data of cases and deaths. Yesterday the was an uptick in usa cases. That was expected due to kits being distributed on a wide scale this week. So the key is to look at the death rate. And observe a semi log plot to see if there is an exponential rise in rates. So far there is no exponential rise in the USA death rate but it is early and we are talking about small numbers .
For the last 3 days Italy has taken a big hit with over 100 deaths daily.
My first reaction was Dr. Chu is trying to blame-shift the virus away from China. How can she make the statement “It was here all along” based on one test? Dr. Chu may be an American with no interest in helping the Chinese save face but her entire behavior here is curious. There a reason we don’t let medical testing be done willy-nilly.
Medical ethics >>> Is lab-testing the equal of search under 4A
It must have been here this entire time,' Dr. Chu recalled thinking with dread. 'It’s just everywhere already.'..
This is what i've been assuming
Last January, i had a slight fever and cough; about 10 days later, instead of going away
became
shortness of breath and difficulty breathing; if i laid down, i couldn't breathe without coughing up phlem. I was thinking that i'd gotten pneumonia
Then, after a day and a half; it started getting better.
Did i have covfefe-19? i'm NOT saying that; i'm just saying i had EVERY Symptom
EXCEPT contact with a KNOWN carrier
Since writing my previous comment I clicked over to the article and read it. My initial suspicion of Dr. Chu’s motives were somewhat diminished. My new suspicions are that the NYT wants to besmirch the Trump response. Sad, but I’m sure half the country feels that way about every news piece. We have all become suspicious consumers of information. A little skepticism is healthy but we’re far past that now. And I blame the Left almost entirely.
Federal bureaucracy is terrified of getting caught breaking regulations on their own motion.
Regulations I've dealt with started out reasonable, devolved to awful, got reasonable then devolved to merely bad.
It's a fat hog when the regulations are bad.
If it is everywhere already it’s less of a threat than the flu.
The virus spreading unknown and unchecked for a month and a half in Washington without the medical system and society as a whole breaking down kind of undercuts the narrative. Spreading unknown and unchecked has been held up as a crisis and it already happened without a crisis. But the media will never report that. That doesnt help them in their latest Don Quixote swing at finally getting Drumpf.
Medical ethics on testing should be simple.
If you can test for it, at no additional cost to the patient, and are curious, do so. If it's positive- TELL THE PATIENT!.
I give blood every 8 weeks. Part of the consent I sign is a release saying they might test my blood for all kinds of things. And if they find something, I certainly hope they'll tell me. What's more intrusive is that every time I go into the VA they test my blood for all kinds of illicit drugs, because I get my oxycodone through the VA. I get a 30 day supply about once a year to take care of pain and to use as needed. So my 30 day supply last about 365 days. But I'm tested to see if I'm a drug abuser... I'm going in next week, I still have 10 pills left over from last year's supply.
If I recall, one of the problems in the aftermath of Hurricane Katrina was that professionals (doctors, firemen, etc,) who volunteered were forced to attend trainings on all sorts of unrelated matters because of federal regulations. They just came eager to help and ended up listening to lectures before they could do anything. I don't know for certain if that's true, however.
If in fact the virus is everywhere, that means that it is a whole lot less virulent than we thought. Deaths due to the disease are pretty obvious. People with mild symptons who recover on their own, not so much.
Incidentally, we are told that errors in the FISA process are due to weaknesses in longstanding policies and procedures, and nobody's fault. Yet apparently the same standard doesn't apply to the CDC. It's Trump's fault, who is even farther away from the day to day than the top management of the FBI.
I agree with Howard on bureaucracy. This has nothing to do with medical ethics. The subjects agreed to be tested. The China connection with Seattle is heavy and has been for years.
the main cluster was at the living facility, where else doesn't precision in language matter,
If in fact the virus is everywhere, that means that it is a whole lot less virulent than we thought.
Extensive testing will give us the death rate. The important study is the one testing the effectiveness of remdesivir and Chloroquine in severe cases.
Did Dr. Chu come from China?
Yeah, I doubt there's any sane person who would have a problem with being tested for coronavirus at this point.
M Jordan: "My first reaction was Dr. Chu is trying to blame-shift the virus away from China. How can she make the statement “It was here all along” based on one test?"
I didn't read it that way. I agree that her conclusion seems to be a hell of a reach from one test, but I'm also hesitant to attribute the leap to her rather than sloppy journalism without further info. Misattribution and miscomprehension in science reporting are just too common.
It seems more likely than not to me that the virus was circulating around the U.S. before the big breakout in China. That doesn't mean that it didn't ultimately originate in China.
the remdesvir trials are starting now, but stupidly, the investors aren't interesting in funding the companies involved,
"Scientists have discovered that being alive is actually a form of disease." -- Georg Carlin
They quickly had a positive test from a local teenager with no recent travel history.
But is it a false positive? Need a second test to confirm.
Coronavirus makes medical ethics look like red tape.
I read it as red tape disguised as medical ethics.
"Did Dr. Chu come from China?"
That's a racist question! You wouldn't ask if Dr. O'Rourke or Dr. Weinbergstein came from China!
So let's have the government more in charge of health care!!
Once again the "experts" in the bureaucracy know best, and keep following their rules regardless of circumstances. (Yet the Democrats want to put them in charge of everything.) At the very least, the data could be anonymized (?) to give useful information about the spread of the virus without identifying any individual. Desperate times, desperate measures.
this is the regulatory world we've built in education, healthcare, government, and business.
A couple of years ago, after I had retired, the folks I used to work for wanted me back for some consulting. They suggested putting me on timecard as an employee, but for shits and giggles I decided to see how working as an independent consultant would work. Big mistake. The money came out of a government contract, so I spent a good part of an afternoon with HR filling out 40+ pages concerning regulations about non-discrimination and other such things. All that for a couple of hours of my time. Next time around I did it for free.
I give blood every 8 weeks. Part of the consent I sign is a release saying they might test my blood for all kinds of things. And if they find something, I certainly hope they'll tell me.
You might want to check that consent again. It usually states they do not have to tell you. If you disagree with consent, then they assume you are hiding something and, depending on the need, will likely discard your blood.
henry said...
Election optics overrule truth. That covers politicians and the media. The rest of us get stuck with the bill- both financially and biologically.
Um, no
The Federal officials who were screwing that up were all members of the "health care deep state". Bureaucrats, not political appointees.
It wasn't President Trump who was screwing this up, it was and is the Democrat "civil servants" who are doing so.
You know, the "cognitive elite" "experts" who that "idiot Trump" so "wrongly" ignores.
If you read that article and thought ""wow, Trump screws up again", you're an idiot
Machu said...
It's amazing how quickly and eagerly people are will to give up the rights of others when they're scared.
You don't have the right to get other people sick.
You test every single swab, then you inform every single people who's infected that they're infect.
And then every single one of them with a functioning brain thanks you.
Seriously, Machu? "Hi, we tested that swab you gave us, and the test indicates that you have been infected with coronavirus. The lab which did the testing is not certified for clinical use. so to get a formal diagnosis, you should contact these people, and they'll take care of you."
Because of course, in a rational world, the CDC would have teamed up with them, and made sure that everyone whose swabs tested positive could quickly get the official test.
now, in that situation, you're telling us you would (to your mind rightly) be upset that your swab had been tested for coronavirus, rather than (rightly) happy that you were informed, and could take precautions (like, you know, get the full emergence treatment if necessary, and so not die)?
This was a victory of form over substance. What kind of nut celebrates that?
"The coronavirus had already established itself on American soil without anybody realizing it. 'It must have been here this entire time,' Dr. Chu recalled thinking with dread. 'It’s just everywhere already.'"
After reading this, and similar medical articles, I realized that the persistent cough that ran the gamut of my (Madison, WI) workplace last summer was most likely Covid. Same thought from a friend who's family contracted a persistent cough on a cruise ship last year. Put me in the camp that believes Covid has already taken at least one lap through the country and no one even noticed.
This is actually reassuring to me. I've been operating on the assumption that the virus has been here for a while, despite efforts to try to "contain" or slow the spread of it. It would have been impossible to contain something that would have started to spread before the world woke up to its existence/danger.
The reason this is reassuring is that apparently it is endemic - perhaps widespread and it has not overwhelmed our health care system. That would be great news!
Had anyone here ever read the HIPAA agreement required at every medical office? Just curious. Whom does it protect - it sure doesn't cure anyone - just like no one in the Department of Education educates anyone.
O well.I
There are two strains of this virus going around. One is much more deadly than the other. What if the least virulent strain is the one here already.
"Anyone know the rate of false positives for us tests? My understanding is that it is pretty high but I could not find a number just now."
No. This is a problem with all such RT-PCR tests- you have to validate them with extensive controlled studies and frequent modifications where the validation effort fails. None of this has been done by anybody to date. I suspect this is one of the reasons the CDC was slow in getting this going- they were trying to validate the new tests for COVID-19. Now, in certain kinds of RT-PCR tests, one can monitor the progress of the PCR portion and get a good guess about whether a positive result is valid or is just a false positive caused by errors in replication.
I'm sorry, it is not racist to suspect someone to have hidden ties to China. We are finding out more and more that many in academia, business, and journalism have some sort of connection to the Chinese. Anything that reduces China's culpability in anything is suspect, and should be looked into. I don't trust them!
Goodbye to Rosie
The Queen of corona
Killin' me and Julio
Down by the schoolyard
These people did not give permission for you or Dr Chu to search their blood and you and Dr Chu have no reason to suspect they're more likely to be infected.
This was a nasal swab. It was part of a study of infectious diseases. I just don't see the big deal.
One time we had a drunk driver come in the trauma center. He had hit an d killed a kid. We routinely tested BAC on all traumas but the cops said only the official lab tech could test the BAC. So we didn't test.
A year later they came to me and asked me to testify in court because the lab tech had f**ked up the BAC. I had to go to court and testify the driver was drunk clinically because they wouldn't let us do the routine BAC.
Eventually, when the history of this disease is written, you will learn that the first cases of COVID-19 in the US (and most of the rest of the world) occurred in 2019 and maybe even 2018. People will eventually have the time and the resources to examine the swabs taken from influenza patients from those two years, and the swabs taken from people who died in hospitals from respiratory failure- it is just no one has looked yet.
This morning, Angela Merkel basically admitted that the virus was already so widespread that efforts to contain it in Germany were going to fail. I think part of this is some of the retrospective testing has started to happen and showing the virus had already spread temporally before early January, and had already spread geographically.
At a certain point, we face a decision- selective quarantines don't work because the virus is spread too far and deep- only a total country-wide lockdown can stop it. Now, do you think that can be done in a western 1st world country? In the end, is it worth it? If, after a month long lockdown, you find out 3 months later it is spreading again, and you still have no vaccine, what do you do- lock down for another month?
I think, eventually, we will just have to accept the virus can't be contained because we learned of it far too late. We will just have to deal with the consequences as rationally as we can, and if the seriousness is as bad as the doomsayers say, then that will require triage and hard decisions about who to try to save.
OTOH, can the researchers, I would say other than Dr. Chu, be trusted not to exaggerate their finding?
Some Democrats declared if they had the virus, they would deliberately expose Trump supporters. Democratic Deep Staters have recently launched a failed coup, and a failed impeachment. If researches were done by Democrats, can we believe them not to exaggerate to score political points?
The Chinese are floating the accusation that the virus originated in the US and was reported as H1N1 flu. Then the virus was brought to Wuhan by the US military who participated in some athletic games in Wuhan last summer. The Koreans and the Japanese spread the pestilence to the rest of the world. The Japanese and the Korean now are calling the virus Wuhan Virus.
How soon will Democratic scientists parrot the Chinese version of events?
Agree with Yancey Ward.
Additionally, since the virus is widespread I don't know why there is such focus on testing. Confirming a patient has this virus, at this point as I understand it, is not going to change any treatment. It may be wasting effort and resources.
Open to being persuaded differently.
"But is it a false positive? Need a second test to confirm."
They could retest the original sample if they didn't use it up. Testing the teenager after his recovery would still interesting from a policy point of view, but the test might be negative for virus load, however, they could test for the antibodies with an ELISA test. I would think an ELISA for this disease has already been developed- it will be important going forward in determining how widespread the actuall disease was.
Darrell said...
Did Dr. Chu come from China?
I heard she is marrying another prominent colleague, Dr. Hideki Ah.
She plans to hyphenate her name, so she'll be Dr. Ah-Chu
Last week, when covid first began to dominate the news, I caught cold. It was kind of weird since I haven't had a cold in ten years. At my age I've been exposed to nearly every coronavirus except for possibly a novel one. My cold was quite mild and brief, thank God,but I wonder, could I have already had covid-19?
I’ve read the average age of death in CV patients in Italy is 81 while worldwide it’s 80. I’ve also read that zero children have died from it. Is it wrong then to compare this virus to an ice storm that brings down the dying and dead branches above? Nature’s pruning? And does that make me an ageist for even thinking that?
If so, I’m guessing just about everybody’s an ageist. It really does seem this is just a bad cold. It’s a cold I don’t want to get but still, just a cold.
Are you with me Doctor Chu?
Am I really just a shadow
Of the man that I once knew
Got a virus and it's bad
Took all the fun that I once had
Has it finally got to you
Can you hear me Doctor?
Blogger Machu said...
Me: You don't have the right to get other people sick.
Yea... that was exactly my point
Of course you don't have the right to get someone sick. You also don't have the right to randomly test someone for something against their will. That's the whole reason police require probable cause for searches. These people did not give permission for you or Dr Chu to search their blood and you and Dr Chu have no reason to suspect they're more likely to be infected.
No, that's my point. You are fighting for treating "find the disease carriers" the same as "find the criminals"
It's not.
1: Chu's not testing their blood. Chu's testing nasal swabs
2: The point of the test is not to arrest people, it's to let them know they're infected, and should seek medical help.
3: They were giving those medical swabs so they could be tested. Adding another test, NOT for the Doctor's personal research, but to protect public health in general, and the health of those specific people, is not an ethical violation
4: This doesn't excuse the FDA whine that "the labs you're using aren't clinically certified". So what? Get the people go to a clinically certified lab to re-test, if they test positive on the first pass
I get that you're scared, but that doesn't give you the ability to deny other people's rights. If probable cause is required for searching someone's property it certainly should apply to their blood. People who volunteer for clinical trials have the explicitly stated right to know what their samples are used for and you and Dr Chu don't get to decide when that right no longer applies.
1; I'm not scared. i', just not a moron who can't tell the difference between bureaucratic formalism, and rational behavior
2: You don't have a right to infect other people. being sick is not a crime. bringing criminal rules into health situation is something you only do when your'e insane
3: So Dr. Chu informs everyone that their sample has been tested in a research lab for coronavirus, and tells them what their results were, and what the false negative / false positive rate is thought to be.
That's my point, it's not up to you to decide if it's a big deal.
No, that's our point: we're in a pandemic situation, and it IS our right to decide if it's a big deal.
Apparently you're one of the people whose very limited knowledge and understanding of the world only extends to a time when antibiotics / vaccines could deal with anything important. Reality check time: that's no longer the case.
You don't have the right to get other people sick. Society has the right to protect itself against sick people. That includes enforcing quarantines, engaging in contact tracing, and testing people, even if they don't want to participate.
The world is round. Stop demanding we all act like the world is flat
I looked at the article to see how many people tested by Dr. Chu got COVID-19 and how many died. Strangely, the article didn't follow up and mention any. Yes, there were many deaths of infected people at the senior facility in Seattle but I saw no connection between them and those identified by Dr. Chu who tested positive.
So theoretically it would be nice at the first sign of any new outbreak if we could instantly test millions of people and isolate the infected individuals but is that at all possible?
Rosalyn C. said...
I looked at the article to see how many people tested by Dr. Chu got COVID-19 and how many died. Strangely, the article didn't follow up and mention any.
It's the New York Times. It's intelligent of you to look for that information.
It's naive of you to expect the NYT to actually be informative. :-(
A couple of years from now, someone will go through the samples, and samples taken from the hospitalized people, sequence them all, and see if they can work out a "Wuhan Flu family tree", attempting to establish who infected who, and what could have happened if Dr. Chu's samples had been immediately used.
For now, all we have is that we have people who could have been helped, but weren't, because the bureaucrats at the FDA and CDC were more interested in promoting their empires, than in actually doing their jobs
"Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects;"
As someone who did research with human subjects and had to abide by the HIIPPA bureaucracy, I have some experience with this. The rules are, in many cases, insanely stupid. It doesn't surprise me in the least that they may end up killing people. Example number 1000 and 1 of why I hate big government.
Socialized medicine. All the efficiency of the Post Office. All the compassion of the IRS. All the intelligence of your average socialist.
Her patients gave informed consent for a flu study (as far as I can tell, I haven't read the IRB). They did not give (again, as far as I can tell) informed consent for a cornovirus study.
They gave consent for a blood draw, which was to be tested.
Machu said...
Me: You don't have the right to get other people sick.
You seem really hung up on this. Did you miss the obvious sarcasm or do you honestly think anyone anywhere is arguing that you have a right to get other people sick?
You, right here, are arguing for the right to get other people sick. you are arguing that it is a transcendent right, above all others.
Because if that were not the case, then of course you test the samples, and of course you inform everyone who tests positive that they did.
Who gets to decide if it's a big enough emergency to violate people's civil liberties?
There you go again, arguing that this is an issue of "civil liberties", which is to say, their right to get other people sick.
They consented to having samples taken. They have a right to know the results of any tests done on their samples. They do NOT have a "right" not to have the samples tested for a new infectious disease that is rapidly approaching pandemic status.
I am literally a vaccine scientist.
Congratulations on your rather well developed case of Stockholm Syndrome. "These are the rules, we must follow them no matter how many people die."
Wrong.
I understand the rules. I understand why they are there, and I'm familiar with many of the ethical violations carried out by "research scientists" such that the rules were created, and are necessary.
I also know how to differentiate between form and substance. According to the John's Hopkins Wuhan Flu tracker, there are 29 dead in the US from the WuFlu. 23 of them are in Washington, apparently all in Seattle.
273 total cases, of which only 1 is someone scored as "recovered."
How many of those people are sick / dead because people at the FDA and CDC, like you, can't tell the difference between "research" and "public health"?
"These patients did not get that chance, therefore their rights were violated. Allowing the PI of a clinical trial to be the solo decider of what rights are and are not a 'big deal' seems like a slippery, very easily abused slope."
Oh, no! The dreaded slippery slope.
Please explain how these subjects, in this case, were harmed.
Late to the party. Could the subjects simply have been asked via mail,telephone or email if their sample could be tested for the new virus?
"Could the subjects simply have been asked via mail,telephone or email if their sample could be tested for the new virus?"
I bet this request was put to the IRB, who than sat on it.
These patients did not get that chance, therefore their rights were violated.
Don’t be a snot stooge!
Fascinating article, and it says more about multiple bureaucracies and the tension between private and public rights than it does about the coronavirus spread.
But, it supports Yancey Ward's thinking that the virus is and has been widespread long before it was ever noticed. I'd guess a vaccine, available in about a year, will likely be too late to do much good.
"Natural immunity" should arise from some level of exposure -- not too little, not too much (which might cause overt disease). So, I wonder if the zeal for self-isolation and / or quarantine is both moot and even counterproductive.
If you want a chilling thought, just imagine how many more "novel" viruses are out there developing an epidemic level threshold of transmission.
It’s sad, really, that the media has spent the last four years on one fraudulent story after another.
“But there’s a wolf this time, for real; trust us.”
Sounds like supply of test kits isn't an issue as much as available facilities and trained technicians to process tests. Seems like the sort of thing where funding to train lab techs and set up facilities could have a relatively quick impact. Hard to detect infections early, and limit contact with known carriers, if testing is scarce.
As a side note, how many flu cases has there been this year and how many have died from the flu? How do those numbers compare to last year, or the last 5 years?
While a lot of people become incensed by comparing it to the flu, it’s a good baseline to understand perspective, how it really compares, and how effective any quarantine efforts have been in combatting one of the very common illnesses that kills a lot of people every year.
In addition, details regarding how the people died is pretty thin; specifically, the younger people who died.
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