So it was halted because the original requirement for this sort of testing program was for surveillance, not diagnosis. Washington's public health authorities chose to change its intention and purpose (to instead provide the results immediately to patients, also known as diagnoisis) while still expecting the FDA to approve it. This is just a case of one bureaucracy not being forthright with another one, and I don't see why the fact that Bill Gates "backs" it has anything to do with the program.
Is Bill Gates somehow involved in this decision? Because one would hope that a private individual would not be have undue influence on public health organizations' decisions, especially when he has much of his wealth invested in the very industry that is likely to be affected by the results of this Coronavirus study. It's an overt conflict of interest.
> especially when he has much of his wealth invested in the very industry that is likely to be affected by the results of this Coronavirus study
Citation needed. As far as I can tell, his only healthcare related holding is Schrodinger, Inc. which is new, and at 300M out of his 106B net worth could hardly be considered "much of his wealth" .
I was wrong, and thank you for pointing it out. I conflated his Foundation with his person. And you are correct, "much of his wealth", is misleading. It is the hundreds of millions of USD in his private healthcare investment and several billions under his control through his Foundation [1] that I know of. Given how extremely wealthy and powerful he is, I think that even though it is not a majority of his life on the line, it is a lot of control, influence, and maybe a teensy bit of a return on investment, that he has to gain from this.
A charitable foundation is something rich people start to launder their reputation after a lucrative career of skulldaggery. Once you have more money than God you don't need an ROI for your bank account -- you need one for your soul.
>I don't see why the fact that Bill Gates "backs" it has anything to do with the program
I doubt the FDA's decision had anything to do with the Gates connection, but most study rejections don't get articles in the NYT. His backing is why it's "news," he spend/gives millions to the press to ensure it.
> His backing is why it's "news," he spend/gives millions to the press to ensure it.
No, it's news because the FDA is haulting COVID testing over utterly stupid bureaucracy when we need massively ramped up COVID testing and SCAN/Seattle Flu Study are actually providing quality home tests at scale.
This stands in stark contrast to the hundreds of poor quality home antibody tests the FDA has approved with almost no oversight. It seems inconsistent with the need to cut red tape to fight COVID.
“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.”
This story strikes me as off. It runs counter to every other aspect of the virus we focus on. Specifically, if it was already spreading in schools, then why don't we see scores of critical kids and parents? With how contagious this is, I find it fairly unconvincing that it was just that student.
Combined with symptoms taking about a week to present, this was in community spread for a while. Yet, here in WA, the deaths figure is still 92% over sixty years old. I don't know the percent from long term care facilities. (I would love that stat.)
Then the question is at what point did it break into long term care facilities? And could we have done something to strengthen their protection?
With a further question of what, exactly, causes it to go severe.
From what I can gather, they allowed a free signup for participants. People with flu-like symptoms are more likely to be searching for tests and to go through the hassle of acquiring a test.
They don't send kits to everyone who uses the website, and they ask "do you have symptoms?" in advance of asking if you want to be tested. Certainly there is some self-selection bias in using the website at all. That would also be true if they did not provide results. Regardless, it has nothing to do with the TFA and the FDA's actions.
>That would also be true if they did not provide results.
Both sides would have notably different biases that would need to be accounted for, and would have different guidelines for FDA approval. Pausing the project when you discover there was a miscommunication over what kind of testing was being done makes sense. You need to keep the potentially tricky data separate from further results.
>Regardless, it has nothing to do with the TFA and the FDA's actions.
It's the actual reason they gave for their actions, and their request for more information on tests done to people not showing symptoms would be one of the main things they need to determine what bias is present.
I disagree with that - at least in this instance. Perhaps in other situations, but if you're suggesting that a program between the major state and city health departments in Seattle (which was one of the earliest known COVID-19 cities) _about_ COVID-19 being halted would otherwise "not be news", I'm going to have to disagree.
For a start, it wasn't "canceled," it was halted until proper authorization is obtained.
I don't really see the point of most of the stories about various ongoing tests. Until something is shown to be effective, what benefit do we get from learning all these details?
You're right. I wish NY Times were slightly above this practice, of including a polarizing celebrity with no relation to the story as if he is either A. an authority, or B. an actor in the narrative. This attracts both the audience who thinks Bill Gates' work is humanitarian, and those who think he is doing this for selfish (money/power/influence) reasons. It seems his only connection, from what I can tell, is proximity and endorsement, which are irrelevant, and only tangential to the story, which is already scant.
This is pretty similar to the 23andme shutdown years ago, and for the same reason. The FDA regulates what kind of “medical advice” you are giving. From the article:
> The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients.
> “We had previously understood that SCAN was being conducted as a surveillance study,” the spokesperson said.
...
> Dr. Topol said it would not make sense to have people swab their noses and then not give them their test results.
> “To withhold that information from people is downright absurd,” Dr. Topol said.
While I agree with the sentiment, the 23andme situation provides a useful counter balance: if you provide untrained people with inaccurate results, is that better or worse?
In the 23andme case there was a worry that people might commit suicide or make massive life changes, if they discovered they had a potential terminal illness. Here, the 2x2 matrix of positive vs negative and true vs false, seems most dangerous on the false-positive side for people who believe it grants them freedom to do whatever they like. False negatives are dangerous for those who then feel certain they don’t have the disease currently and thus expose others unwittingly (but this is already likely!).
So I dunno, I bet they’ll review this somewhat quickly (the group sent their FDA materials in a few weeks ago according to the article) particularly once they have a tighter estimate on the false positive and negative rates.
So unlike 23andme, (1) realtime COVID diagnosis is extremely timely and actionable to recipients and has a real impact on disease spread, (2) the SCAN tests are reliable, targeted, and they have the data to support that, and (3) a positive or negative COVID test seems unlikely to induce suicide, or I don't know, a murder spree. So I don't think this comparison is especially suitable.
In addition, the informed consent form for participants has included language that results might be shared since early March: https://pastebin.com/wj6fMnrw So the FDA, in May, claiming to think the study was only surveillance suggests to me a remarkable failing of comprehension by the FDA.
> The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test
> We have been in conversation with the FDA since March 1st and hope to have our EUA soon. We initiated the process to authorize our lab-developed test and self-swab kit on March 23rd and, in accordance with the EUA process and timeline, submitted data to secure federal authorization on April 13th. We are actively working to address their questions and resume testing as soon as possible.
> We have performed internal studies to determine shipping and specimen stability with our assay, testing approximately 17,000 home-collected mid-turbinate swabs from both adults and children—including Seattle Flu Study and SCAN samples. We have provided the following information to the FDA:
> To date, only a single, minor adverse event has been reported.
> Our shipping and stability studies have established that detection of SARS-CoV-2 is stable for over a week at high and low regional temperatures.
> With regard to proper specimen collection outside of a clinical setting, our experience from more than 18 months of sampling with the Seattle Flu Study and now SCAN also shows a low rate of insufficient nasal sampling. The internal control in our assay readily identifies whether a sufficient specimen is collected.
> Numerous scientific studies have established similar rates of detection for mid-turbinate swabs and the nasal pharyngeal swabs typically used in clinical testing, including for SARS-CoV-2 detection. The Infectious Diseases Society of America (IDSA) guidelines endorse the use of mid-turbinate swabs and reference the potential for self-collection with appropriate instructions.
> In the 23andme case there was a worry that people might commit suicide or make massive life changes, if they discovered they had a potential terminal illness. Here, the 2x2 matrix of positive vs negative and true vs false, seems most dangerous on the false-positive side for people who believe it grants them freedom to do whatever they like. False negatives are dangerous for those who then feel certain they don’t have the disease currently and thus expose others unwittingly (but this is already likely!).
Isn't that the suggestion? That if there are groups of individuals who you know are going to make wildly irresponsible choices because they don't have the ability to interpret such information, you would prefer not to give it to them?
It's entirely reasonable to assume that tests with high error rates cause problems for everyone, not just "groups of individuals who you know are going to make ..."
For example, a PhD biologist friend of mine agonized for months before she was willing to look at her personal 23-and-me results, after the FDA certified them as accurate enough to show to consumers.
No, I was just calling out the "you know, the outcomes just aren't that bad here". As I ended on, I think they'll come to the conclusion relatively quickly that there is minimal risk to the public from having such diagnoses, even if they're misinterpreted.
The FDA doesn't object to the surveillance study, just the part where SCAN actually give individual test results to study participants ("diagnosis"). Nevermind that the informed consent form has explicitly told study participants they might get their results ("diagnosis") since early March, after the last time the FDA "helped":
Doesn’t matter, testing the populace for public health matter like trying to control an outbreak is the right of the state. Telling people results is needed so people can self quarantine. State has the ultimate authority. Washington should tell the Feds to go pound sand on anything covid related including what tests to use. There are multiple Supreme Court rulings on this matter.
> testing the populace for public health matter like trying to control an outbreak is the right of the state. Telling people results is needed so people can self quarantine.
I agree with this part. As to the rest, I am not a lawyer.
What I've gleaned from the Theranos saga is that the FDA has an office of criminal investigations and can refer cases to the DoJ for prosecution if there is a crime. I don't know if there would be a crime in that hypothetical scenario; Theranos was charged with wire fraud, and this is pretty clearly not wire fraud. I don't know if there's any recent historical precedent (since WWII) for researchers violating the FDA's notion of informed consent. It may be a type of negligence crime although I think the FDA has a pretty weak case for that.[1]
Stealing PPE. Stopping legitimate test programs. What else is the federal government doing to actively hinder the pandemic response and kill people? Not to mention everything they are not doing.
> Stealing PPE. Stopping legitimate test programs. What else is the federal government doing to actively hinder the pandemic response and kill people?
Using the Defense Production Act to order meat plants open (and thus prevent states from taking action to close them or make them safer if they are to remain open in the light of massive outbreaks at many of them.)
It’s become painfully obvious that the trump admin doesn’t want want testing rolling out too quickly. It would appear as a new wave of infection and spook the all important Stock Markets.
I don't get it. From what I can gather they are not testing a new medicine or vaccine, this is purely testing. So there is no harm to patients at all. All they are trying to do is understand the pandemic and the virus. Why stop it? Correct me if I am missing something really obvious here, but I cannot help but think it could be politically motivated given that its bringing out dozens of previously undetected infected patients. I really hope its not the case but cannot stop thinking about it.
There's also harm if you don't tell them a correct result. There's especially harm if you stop testing their neighbors to monitor community spread during a fucking global pandemic over this pointless red tape about providing results.
Thank you for elevating the discourse with phrases like "fucking global pandemic over this pointless red tape". A global pandemic is exactly when we should be thinking hard instead of trading insults.
Pointing out that someone is using silly language with pointless effect is not an "ad hominem attack": can you point out anyone who might be confused by what I said?
Your use of "my friend" is similar to the thing you're complaining about. I got what you mean. Bringing up "ad hominem" is dodging the real issue.
Another comment of yours: "utterly stupid bureaucracy"
I think it’s more nuanced than that (see my other comment).
If you have a false negative, then maybe they spread the disease more than they might have otherwise (unwittingly, but now with the “certainty” they don’t have it).
If you have a false positive, the main downside is from people who think “great, I’ve had it / got it, I’ll be immune shortly”. So that’s the main risk to them.
In addition to the points raised above, a false positive could also have negative impacts on income (unpaid sick leave to self-quarantine).
The false negative hypothesis is facile; even if you don't have it, you can still get it. Ignoring social distancing on that basis wouldn't be any more sensible than doing so without the test. To the extent that some people are just idiots, a false negative diagnosis does not change that.
There is also harm to telling them other incorrect facts, but we generally consider a ministry of truth to be a bad idea. Yet we tolerate the ministry of food and drug truth. This story underlines the cost of that.
I expect the ministry of food science and the ministry of drug science to be scientific. That's quite different from what you're talking about.
I have noticed that your comment is quite typical for people who want to say that we live in a post-truth world. There are certainly problems, but one solution is to double down on science.
Yes there is. If the test fails, and they report to the patient that they do/don't have the virus, that can cause significant harm to the patient and others. We don't know how accurate these tests are, which is why a surveillance test is needed. (Or different standards would allow a diagnostic test, I'm not sure)
Beyond the reliability of the tests, which has also been questioned of those by Abbot Labs (the same tests administered to the President), the FDA states they simply need further inquiry.
Tests do not inject you with any form of matter or fluid. Why are we completely halting testing, even if it is only 1/3 correct? Just disclose that fact to the testee and/or use 3 tests for a statistically significant result.
Does this reek of backdoor capitalism (corruption)?
It’s more likely they don’t want testing rolling out too quickly. It would appear as a new wave of infection and spook the all important Stock Markets.
Ding, ding, ding we have a winner. This is the same FDA that stopped ethanol producers from making hand sanitizer, at the behest of the purell of course[0]. The feds have done practically nothing for the States making them compete each other for ppe and also confiscated shipments [1] while saying the national stock pile isn't for the States [2]. At this point I hope they just ignore the feds. We might be better off revisiting the articles of confederation at this point.
> In one case, the FDA said it had found significant levels of the carcinogen acetaldehyde in ethanol supplied by a company for use in hand sanitizer, according to a recent email exchange seen by Reuters.
Is anyone surprised that using fuel ethanol might not be a good idea for hand sanitizer?
They also stopped distilleries from doing so. Unless the argument there is "you can ingest alcohol made in this facility, but not put it on your skin"...
> Acetaldehyde occurs naturally in coffee, bread, and ripe fruit,[10] and is produced by plants. It is also produced by the partial oxidation of ethanol by the liver enzyme alcohol dehydrogenase
Doesn't really sound like a problem in a topical solution like hand sanitizer given people ingest it regularly.
I don't see any explicit guidance on Acetaldehyde. The requirements show 95% ethanol for ethanol-based sanitizer, with a footnote saying actually, "Lower ethanol content alcohol falls within this policy so long as it is labeled accordingly, and the finished hand sanitizer meets the ethanol concentration of 80%."
It goes on to add, "Ethanol produced in facilities normally producing fuel or technical grade may be
considered for use if the ethanol is produced from fermentation and distillation as would
be typically used for consumable goods, and no other additives or other chemicals have
been added to the ethanol. ... Because of the potential for the presence of potentially harmful
impurities due to the processing approach, fuel or technical grade ethanol should only be
used if it meets USP or FCC grade requirements and the ethanol has been screened for
any other potentially harmful impurities not specified in the USP or FCC requirements."
Edit2: Here's the USP guidance on hand sanitizer, which lists Not More Than 10uL/L Acetaldehyde / Ethanol:
https://www.usp.org/sites/default/files/usp/document/health-... Again, it's an ordinary metabolite of ethanol in the body, so this is probably pretty conservative.
Wikipedia notes, "After intravenous injection, the half-life in the blood is approximately 90 seconds." https://en.wikipedia.org/wiki/Acetaldehyde#Exposure_limits and "According to European Commission's Scientific Committee on Consumer Safety's (SCCS) "Opinion on Acetaldehyde" (2012) the cosmetic products special risk limit is 5 mg/l."
Ethanol-based sanitizers can be ingested by desperate people. I know what binge can do. These in need found a way to drink denatured alcohol [1], doing very little to clean it up.
So, please add a point to your discourse. In my opinion, FDA did more good than bad for population of US in that particular case.
There are many, many products approved by the FDA that can be abused by "desperate people". Given the limitations on sale, demand, and other things that would appear to be a lesser evil. I'd definitely disagree with the conclusion that preventing this "did more good for the population of the US". Even more so given that many of these facilities were mainly doing "personal" size efforts, 10-15ml bottles. Even at 96% alcohol (which is what the distillery here was getting), 10ml of alcohol won't put much of a dent in the alcoholic who is debating drinking hand sanitizer. It's barely a shot of vodka.
I'm not sure why this comment is downvoted -- it's definitely true, and the FDA does care about stuff that people ingest even if they aren't supposed to.
I don't think you can just use three tests. Whatever caused the false positive is almost certainly a facet of the person you are testing, such that more testing of a single individual by the same test likely should be ignored.
You could do independent tests, though, again it is complicated. The causal factor for the false positive is probably correlated between tests. Such that the math will be more complicated than just the inverse of any false positive rate. (Though, mayhap that is good enough.)
Do you mean regulatory capture? I don't think so. More likely regulatory morass. FDA is still fighting the battle on thalidomide. But in the process, it's losing the war on many other fronts.
Even the Abbott antibody test which is considered a good one is backed by a disturbingly small clinical study. The positive result pool had a sample size of around 75 people, and 1k negatives. I read the reagent insert for this.
Then when labs are running this test, they have very poor correlation studies that are essentially useless. Everyone is trying to rush these tests out the door.
I agree that they should start running them at scale, but all the data needs to be centralized and analyzed. They also need to bring in a lot of previously RNA tested positive COVID patients and see how many test positive.
The problem with all these fragmented efforts with 100 different tests is that we never get the full picture or a good sample pool. I think the FDA does need to apply the brakes here a bit and get this going.
Some statistician correct me if I'm wrong, but that doesn't work. You are assuming the likelihood of a test being wrong on the same individual is random every time it is taken. Which I don't think is something we know yet.
statistically it depends on whether tests are independent; i.e. if the cause of the false positive is to do with the subject then using three tests won't help. if the cause of the false positive is entirely random then doing three tests will help improve the accuracy. if the correlation between false positive occurrence and the testing parameters are somewhat correlated then it may help but maybe not as much as you'd want.
Even worse than that -- even if statistically independent, 3 instances of a 33% individual test chance of true positive does not mean 100% chance of a true positive result after 3 tests. Something like (1 - (1-33%)^3) gives you a 70% chance of true positive after 3 totally independent 1/3 change trials.
