Why the FDA is banning the Gates-connected testing kits

Now we know:

An F.D.A. spokesperson said home collection kits raised additional concerns about safety and accuracy that required the agency’s review. The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them.

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.

Here is the full NYT story, via Paul Novosad.  Just stunning.  Here is Alex’s earlier post on the episode.

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Oh, my God! Information may be transmitted to individuals who could make use of it. Can't have that, can we?

Where do we live, and how did we get here?

Milton Friedman. The number one responsibility of a manager is profit.

At least $100 per test:

"The FDA said the authorization announced Saturday follows two recent authorizations for at-home tests, including another nasal swab test and a test that uses saliva. The agency also said that Everlywell's emergency use request "leveraged data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group to demonstrate stability of specimens during shipping."
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The kits will cost $135 and will be available later this month, according to the outlet."
https://thehill.com/policy/healthcare/498166-fda-approves-at-home-nasal-swab-test-kit-for-covid-19?amp

Need to ban free tests to ensure lots of profits for the same, but high priced tests.

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My guess would be that the standards for accuracy are higher for diagnostic than for surveillance tests, so the concern is that the patients here aren't being informed accurately about the risk that the test is wrong.

Not saying that that's a concern that should rise to the level of suppressing the test in this case; I'm just saying that there's a rational basis for the rule in ordinary circumstances.

What is infuriating is that the FDA officials should know that in this case they shouldn’t be enforcing the rule.

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The bureaucracies that be would rather you have no information than imperfect information about your health. Please, government, stop "protecting" me.

No, you can get the same results, just only by paying a much higher price to generate high profits for Trump picked winners.

Eg, Trump is not happy about the British, European policy of non-exclusivity on vaccine technology to maximize the number of producers and the total productive capacity to ensure price equals cost, as I was taught in the 60s was what efficient economies did.

Profit is possible only when scarcity exists, and anything produced in ten million plus lots, whether vaccines or PPEs or burgers, should never be scarce, thus never result in profit.

Well,Ray Lopez should like that.

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"Eg, Trump is not happy about the British, European policy of non-exclusivity on vaccine technology to maximize the number of producers and the total productive capacity to ensure price equals cost, as I was taught in the 60s was what efficient economies did."

Still clinging to that myth that Trump was going to develop a vaccine and ensure no one actually receives it?

do you actually believe he is a cartoon villain?

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This is a great point. No one would ever start a testing company and then make innacurate tests. So there is no need for any oversight.

Welcome to AT's much better world.

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So long as the false positive rate and false negative rate are accurately reported, there is no issue.

Pharmaceutical companies generally don't run clinical trials in house, they contract with a private company, a CRO. Said company is trusted by the FDA to report accurate results. This trust is developed over decades of inspections and best practices. The system revolves around trust.

The issue with diagnostics is that the FDA does not have that relationship with everyday researchers. The exact same issue came up with 23andMe, where the FDA argued that you couldn't even report accurate information unless you say it how we want. This, of course, is patently ridiculous, but it's a byproduct of a scenario where no party trusts the other.

Best scenario here is that the FDA adopt a good faith policy and leave it at that. Or congress steps in and forces their hand. Unless its intentional fraud, its allowed.

I think in general, moving forward, the FDA needs to be less strict about the approval process and more strict about the post approval process. Drugs on the market should be aggressively monitored and pulled if necessary. Similar here, the FDA ought to allow all tests on the market and test them individually, if they don't work, pull them and prosecute those if it wasn't a small mistake but gross negligence.

Then there is no need to make the diagnostic distinction. If the tests don't work, publishing the collective data or informing the patent are both acts of fraud. Which the FDA, to not get in anyone's way, will do separately post approval.

Good point. No one would ever lie about their tests' false positive or false negative rate. And I'm sure the drug companies will be very aggressive about looking for side effects of their billion dollar a year drugs. And not having a placebo group will not be a problem because...government I guess. Look at us solving all these problems.

Well, yeah, if the FDA threatens to pull the drug without monitoring of side effects, they would be looking for them. And clinical trails would still be there ... companies would still have to sell the drugs to doctors. Ideally it would go through an insurance company or medicare so the prices would be set and they could do some verifying.

The current system is if the FDA approves a drug, the insurance company and medicare have to buy it. The trials that drug companies run are generally not representative of the real world. So under this system, an agency approves a drug no one knows actually works and everyone is forced to buy it. the system would work a lot better had the people buying it can vet it themselves, and the FDA can manage drug use in the real world.

I worked in pharmaceuticals for years. Placebo trials are overrated, unless you are willing to throw out standard ethics procedures. Most patients can figure out when they are given a placebo, because they don't get side effects. IRB's sometimes require that placebo patents are notified of the face, which defeats the entire point.

Patients chosen for these trials are highly selected to have no co-morbities. Biomarkers are the standard to determine if the drug works, not quality or length of life. Because you cannot test those things in a clinical trial. Safety studies are generally ok, but placebo efficacy trials are not very representative anyway. And no one is saying that you cannot also order these studies. But they are given less weight, and they should be compared to how the drug actually operates in the real world.

And "Japanese people have a higher risk of side effects" because the one guy in the trial who got the side effect happened to be Japanese, which is the current system, is not a very good way of doing this either.

And again, the system has to work based on trust. You have inspections to account for lying, but generally people don't lie, and you can always blacklist those who do.

I am sorry, basically everything here is wrong. If the FDA threatened to pull a drug the company would pretend to be looking hard for side effects then...just not find any.

"The current system is if the FDA approves a drug, the insurance company and medicare have to buy it." That is...not the current system. Google "Repatha." You can read about the years of work and price cuts that have gone in to trying to get insurers to cover Repatha.

Randomized double blind controlled trials are appropriately rated in the industry and severely underrated on this website. The randomization is critical since you do not know what rate of disease progression or adverse events is in your study population without a control group.

There are many diseases where it is impossible to fill a trial while ruling out all comorbidities. Biomarkers are used sometime, but plenty of trials use survival as an endpoint. Google "Opdivo overall survival." "No one is saying that you cannot also order these [clinical trials]." The whole reason it takes so much time and money to get drugs approved is the clinical trials! If you are keeping them you are not saving an appreciable amount of time or money.

Japanese people...off topic, skipping that. "Generally people don't lie." Look, I am not lying when I say that I come here because Alex and Tyler are smart and I like their perspectives. But I have worked in the pharmaceutical industry my entire career and I promise that the reason it takes a lot of time and money to get a drug approved is that it is hard to make a drug and even harder to know if it is safe and effective. Certainly our current system is not perfect. No private or public entity has ever come up with a perfect system for a task so large and complicated. The idea that there is a big win available by just cutting some red tape is insane. Keep reading Marginal Revolution because it is great. Just skip over the drug industry posts and learn about this industry from a different source. It is a bad match for TC's and AT's background and priors.

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"No one would ever lie about their tests' false positive or false negative rate."

And those people would be incarcerated for the crimes they committed. If your argument is "people disregard the law, thus we need extensive regulation", it's a very weak one.

I am not in jail yet!

My argument is people are going to lie about their tests, so you gain a lot by making them prove the accuracy rather than just asserting it.

Is John Ioannidis going to jail? No. I understand frustration that the current system for verifying test accuracy is costly and imperfect. But just saying we will remove all of the burden for the good researchers and when people lie we will know and put them in jail is not serious analysis. Even with the current requirements it is hard to know who is lying. And impossible to put them in jail.

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We already have remedies for companies that sell junk (fraudulent) products. The FDA isn't needed for that.

In this case, the FDA is behaving as though this test *is* defective and that the public needs to be protected, when that isn't known to be true.

Good point. If the parts of the government that deal with fraud hired a bunch of medical experts and started regulating the drug market that would be different than the FDA because they would have different letters in the agency acronym.

I hear that everyone who believed the Ioannidis study has changed their mind now, so regulation after the fact clearly works.

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God bless Donald Trump for stopping Bill "Plandemic" Gates. #covidhoax

Still watching CNN?

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It is annoying to hear about things like this. But I don’t think it is surprising. If you want sane regulation and oversight during, the agencies need a plan in place for that sort of thing before the pandemic strikes. It just seems hard to get people to change their ways in the best of circumstances, and government is pretty risk averse to begin with, and what we’re doing isn’t just asking them to change their ways, we’re also expecting them to figure out what those changes should be on the fly.

After this shit show is over, I expect, I hope, will do a bit of prep to make things more resilient. Lots of obvious things to do. But every agency and Congress should also spend some time thinking ahead about how to change regulations during a slow burning crisis like this one. If they have done that sort of prep work, it doesn’t seem to show.

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Testing as a guide for public policy (stay at home or not) is different from testing for patient diagnosis and treatment. The former need not be as precise as the latter since it's simply a guide for public policy. In the case of diagnosis, false positive or false negative can have very serious, adverse consequences to the patient. Conflating the two different testing suggests that the potential harm to the individual patient in unimportant. That's not medicine, that's voodoo.

After I donated blood, I was informed that testing suggested the possibility of infection of hepatitis. They weren't accepting the blood, but if I didn't have any risk factors, I probably wasn't infected and I could consult with a doctor if desired.

I didn't have any risk factors and eventually retested negative, but it was good to know that they were informing donors of the possibility.

Informing the test subject of the result is empowerment not voodoo.

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This is a very normal problem with our regulatory system, which is designed to protect patients from themselves. The medical system is very much built around the idea that patients should never be permitted to request tests or interpret results. Only if it is unavoidable, usually for historical reasons, will data be leaked to patients.

It's interesting. Every time we hear about a regulation that is supposed to protect people from themselves, there is invariably an intermediary government-licensed expert on-scene, perfectly happy to make a tidy profit inserting themselves in the middle between stoopid people and their critical data.

Coincidence I'm sure. It's not like those guys have lobbyists.

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This is all because the program is associated with Gates. We are using medications in ways never used before and the FDA didnt intervene. After the FDA initially stopped private labs and academia from developing and using their own tests they let them go ahead. So this far along this is most likely politically driven. Either some local people irritated with Gates and/or someone in the FDA trying to please top management by finding some way to slow down Gates, especially in the area of testing where the FDA has sucked all along.

Steve

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FDA clears coronavirus testing kit for use at home: https://www.nytimes.com/2020/05/16/health/fda-clears-another-coronavirus-testing-kit-for-use-at-home.html

Mulp posted the link a few minutes before my comment.

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A good summary of the results of national testing data: https://www.theatlantic.com/health/archive/2020/05/cdc-publishing-covid-19-test-data/611764/

There is a big difference between the number of tests reported by the states and the number of test reported by CDC. The article at the link goes into detail as why this is the case, but here is an interesting bit of information: "Generally, disease-surveillance data flow from local public-health departments to state governments, and then on to the federal government. But in April, Vice President Mike Pence asked hospitals to start reporting their COVID-19 testing data directly to the federal government. In an email, a CDC spokesperson confirmed that the new website reflected test data from more sources than just states, saying it came from hospitals, private medical-testing companies, and state and local public-health labs. The data that Pence requested fed into a piece of software called HHS Protect, which was meant to serve as a clearinghouse of coronavirus data for the Trump administration, according to a spokesperson for the Department of Health and Human Services. HHS Protect was developed by the defense contractor Palantir. The company declined to comment on the record." Palantir, many readers will recognize, is a Peter Thiel company that is mostly known for providing surveillance for governments.

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Apparently, those people who fear anything related to Gates are the same people who thot the world was flat; thot that only the USFDA could find a solution; that only for-profit BigPharma could be trusted - yikes, how many more conspiracy theories will we have to go thru' before everybody in America has gotten sick & died.
Alex Tabbarok said it best - 'Whoever makes a decision to try (patient), prescribe (doctor), or approve (FDA) a drug must face the trade-off between the costs of prescribing a potentially unsafe medicine (a type II cost) and the costs of not prescribing a drug that could have saved a life (a type I cost). The FDA tends to overemphasize the cost of using a potentially unsafe medicine, because type II costs are highly visible and result in punishment of the FDA, whereas type I costs are invisible and do not result in punishment.'
My point is we rarely see a crisis improve w/FDA intervention - it simply takes too long to get things thru' the bureaucracy.

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Bill gates is a known eugenicist and Malthusian. Good riddance.

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As explanations, incompetence usually dominates malfeasance. But in this case: which Trump donor's business is threatened by Gates's test?

(90 seconds): Gates funded doctor says kill all white people who refuse vaccines: https://youtu.be/MsEIQzkcRZk

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The FDA should be returned to its pre-1962 mandate.

Absolutely. We need more cancer treatments such as laetrile. Consumers are being denied a choice.

We have a tort system that can deal with this

Exactly, that way families can grieve for their lost loved ones with a fat settlement check.

Funny thing about that tort system, when right wingers aren't raving about the FDA, they are busy trying to destroy the tort system too.

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Within days of Chinese researchers releasing the genetic sequence of the virus on on Jan. 10, the province became one of the first in the world to develop a test. A week later, before Case One in B.C. emerged on Jan. 26, it had the chemical reagents necessary to carry tests out, said Reka Gustafson, deputy provincial health officer.

https://www.bloomberg.com/news/articles/2020-05-16/a-virus-epicenter-that-wasn-t-how-one-region-stemmed-the-deaths

An enterprising journalist might want to see if these are connected. Washington State researchers came up with a test very early, and were shut down by the FDA. I wonder if there was cross information flows with the researchers in Vancouver, that ultimately made BC the success story here.

If so I want to thank all the regulators and enforcement branch of the FDA for your kindness and generosity.

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I am not bothered by the FDA requiring approval to verify claims.

Anyone want to guess the false negative rate for the emergency use approved Abbott test used in the White House.

Gates can still use for surveillance use.

Post below if you know it; otherwise, I will post later.

Of course you don't have a problem with it. People such as yourself benefit from a strong regulatory state. This is the problem. Influential technocrats without much democratic oversight such as Bill here are now established stakeholders in this messed up Federal system, and so it's going to just keep growing and growing. The decline of America, ladies and gentlemen.

Anon,

To summarize your comment:

Yada, Yada, Yada.

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I am holding the bag - they stopped the program when my results were pending!

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Whole lot of mood affiliation on display here. Evil Bill Gates. Incompetent Trump. Wise Trump. Evil technocrats. Tort system will protect us. Greedy big pharma. The nanny state. This time is different.

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