Wasn't this the result of the project changing its scope to be outside of what the FDA authorized? They put out a press release [1] on May 14 which explained why they were being shutdown--the FDA authorization allowed them to collect samples but not to return the results. By starting to share the individual test results back to those who provided the samples the program was no longer operating within its authorization and was shut down until a new authorization could be secured.
While I don't agree with the FDA on their response, it seems disingenuous that this article doesn't mention the reason why the program was shut down. It is clearly much riskier to provide individuals with their test results than to collect aggregate data. Consider for example if you gave 1 false negative, and that person then took that false negative as an excuse to return to work -- potentially infecting many more. With aggregate data a few false positives/negatives could throw off the statistics but the standards the tests need to be held to for survey purposes are certainly different than those being used for diagnostic purposes.
> It is clearly much riskier to provide individuals with their test results than to collect aggregate data. Consider for example if you gave 1 false negative, and that person then took that false negative as an excuse to return to work -- potentially infecting many more.
Conversely if they are positive and you don't tell them then they are spreading disease unknowingly. That was what happened with the Tuskegee study. Either way, the solution is to get informed consent. At least that is for an experimental study.
Apparently an additional issue here is that this project wants its data to be reported and used by govt agencies. Which means their protocol must also be approved as good enough for that by the FDA. And the FDA decided on May 11 that swabs taken at home requires further analysis as you say.
They either knew what they were doing and were doing it willingly or they had no idea no business doing it at all. This isn't rocket science, it's basic regulatory compliance in clinical diagnostics. Comparing SCAN's situation to a QC problem at Abbott, which has been in the business of medicine for over a century and modern clinical diagnostics for decades, is disingenuous.
I think the FDA has done an overall shit job at managing this crisis but everyone needs to keep the bigger picture in mind. It might seem like a really good idea to bypass a whole slew regulations right now but it has to be done carefully because those regulations have been written in blood of countless individuals. With over four million confirmed cases, any mitigation or response will be deployed at a massive scale. Any mistake, any oversight will be magnified across tens perhaps even hundreds of millions of people.
Over four million are infected now. A lot more could suffer at the hands of eager arrogance.
You think rocket science is harder than regulatory compliance? At least the rules of physics don't change all the time.
The majority of US health regulations have been written by medical corporations in order to keep competition out. While no regulation is certainly bad, current regulation for a large part simply drives up prices and lowers availability. Far more people in the US are killed by red tape than medical quacks.
The FDA knows that virtually every test is not fully accurate. The issue here was that their approval had been based on a misunderstanding of how the study operates.
>2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first
Halting until authorization is a formal warning, you can't just allow human experimentation without knowing they meet the requirements.
This is the same FDA that forbade researchers from running their own tests in January and February[1], squandering our chance to prevent this catastrophe. It's only because researchers broke the law that we discovered community spread when we did.
100,000 Americans have died from this disease in the past 8 weeks. We can't afford to be cautious. Imperfect tests are better than nothing, especially if there are no bureaucratic hurdles to prevent the deployment of refined versions (such as saliva samples instead of nose swabs).
If not for the FDA, we would have an order of magnitude more testing. We'd have human challenge trials. We might even have variolation experiments. All of these could reduce the death rate by an order of magnitude. At this point it is no exaggeration to say that the FDA is responsible for mass death.
I don't think that people realize the magnitude of the number of deaths that are directly due to unnecessary FDA regulation. The only reason that they found community spread in Washington when they did (a whole month after it had been spreading) is because of researchers who went around the regulations and then got shut down. If they had started their testing a week earlier, and if other states were allowed to test earlier, there would have been quicker lock downs across the country and NYC might have not been hit so devastatingly.
I had hoped that people would see what has happened with the coronavirus testing and realize that these issues are systemic and have far reaching consequences beyond the current crisis.
> It is clearly much riskier to provide individuals with their test results than to collect aggregate data. Consider for example if you gave 1 false negative, and that person then took that false negative as an excuse to return to work
With opening of economy, default will be to go to work. People will need excuse to stay at home and no test means they go to work. And sooner or later, opening of economy must happen.
> An FDA spokesperson explains that anything that requires a person to take samples themselves, at home, raises concerns. For example, the agency wants to ensure that samples remain stable if they end up spending a long time in a hot vehicle on the way to a lab.
Not exactly a baffling secret. At home sample collection wasn't included in the guidelines, sounds like FDA is evaluating and may still give a go ahead.
It's not that baffling or secret at all. The only baffling part is how they thought the FDA's specific ban on doing at-home testing under this provision wasn't actually a ban on at-home testing because people were only taking the samples at home, as though this wasn't explicitly the exact, specific thing this ban was created to stop, and how Nature are going along with this narrative.
If the scientists who have been combing through the documentation were baffled, and Nature News found it baffling enough to report on it, I'm going to need at least an appeal to authority of some sort to dismiss their views on this. Nature News is extremely reliable on these things, and does not do clickbait.
LabCorp and the other providers of at-home testing actually went to the trouble of demonstrating that their at-home collection process worked and wouldn't affect reliablity, and then getting authorization from the FDA. This study didn't - they used an FDA exemption which specifically did not apply to at-home testing.
I think that the article made it clear that there is such a great need for at-home specimen collection that it is baffling that the FDA is going so slow.
1. I take a sample collection at home, as an average-person
2. I leave it on my hot porch for a few days before FedEx picks it up, the sample is invalid
3. Lab tests sample, calls me and tells me I'm clear even when I'm actually sick
4. I go to my favorite bar and decide to intimately swing dance with all the patrons, causing a super spreader event
The only thing worse than not having a test is having a faulty test. The FDA is very worried about faulty tests, or in this case, bad sample collection leading to faulty tests.
The key point that seems to be missed by people is that SCAN was one of the first to identify that coronavirus was spreading in the Seattle area and the US.
This was deeply embarrassing to the Trump administration which was trying everything it could at the time to act like there was no issue.
Shutting down SCAN under a flimsy regulatory argument should be seen as similar political punishment to the doctors early on in China who were muzzled because they were embarrassing the government by admitting the situation wasn’t under control.
The FDA and CDC need much stronger protections from political meddling if they are to keep America safe from disease. Their scientists are still great but the disease at the top is spreading down at a worrying pace.
I understand their concern; however I don't agree that the remedy mentioned in the article is the only path.
Knowing a sample is rendered invalid by mishandling or age might be accomplished by packaging an indicator with it which reacts when exposed to extreme temperatures and/or a chemical timer once packed.
The samples could also be delivered via drop-off to collection stations at hub facilities (E.G. medical clinics or hospitals) and stored in controlled environments for the rest of the process.
There were two remedies in the article that I saw, one is wait for the FDA to approve the protocol, and the other is to change to what I assume is a research study which would.
Is there technology already available for your idea that would make it easier than those? Such as a swab that changes color when exposed to the air for more than 30 minutes or something.
Reagan was in office almost 40 years ago. We have had 24 years of Republican Presidents during that time. Have we:
1) Rolled back social security or Medicare?
2) Rolled back the administrative state in any respect?
3) Developed any significant power back to the states?
None of that happened. Government spending as a percentage of GDP increased, from 30% to 35%. Just more slowly than in the immediate post-New Deal era. Characterizing attempts to hold the line or make modest reforms as wanting to “break the federal government” is a cute bit of rhetoric, but you’d have to be very gullible to believe it.
We’re about to go into an election where 2 of 3 leading Democratic candidates proposed new programs that would take US government spending as a percentage of GDP past that of Sweden. More than half of the economy would be the government, versus a mere third today.
By contrast, did any serious Republican candidate propose a corresponding opposite movement? Decreasing total government spending by 15 points to 20% would take us into the 1940s and 1950s (so still post New Deal). No? That should tell you a lot about how much basis your assertion has in reality.
Is that so? I recall a strong push to get rid of "ObamaCare."
The suggestion here is that the Republicans aren't able to pull back these social programs because even their own constituents would be up in arms. The next best strategy is to so thoroughly break the Federal Government that no one would support it anymore.
Issues like the one posted don't seem to be consequences of financial or other neglect from the federal government thought. There is definitely something else going on here.
I wasn't following politics in the Regan administration, but I assumed destroying the government's competence was potentially the right wing's response to the total failure of the Starve the Beast strategy.
Starving the Beast as a strategy just led to very high government borrowing, which is even worse for taxpayers - now they theoretically have to pay for government spending, plus a real rate interest.
I'm willing to guess that many of the issues in the FDA are not caused by normal left/right politics but by bureaucracy, tradition, and other more behind the scenes issues.
The FDA is pointlessly obstructing our coronavirus response, everyone knows they're doing this, but there are no serious proposals to do so much as temporarily bench them. If it's an accelerationist strategy, it's not a very good one because we're not accelerating towards devolution.
I've noticed that this is a position which many people will reflexively consider nuts. I think this may change over time and turn into a partisan issue. Probably one in which the left takes the wrong side, sadly.
I think communicating positions like this is a major unsolved political messaging issue. How do you say "this government agency is unreformable and we need to get rid of it" without implying that the government should completely ignore the agency's responsibilities? It'd make things a lot easier if there were a good way to phrase that.
You would need to at least hint on how what to do about that agency responsibilities. If you said that you want to abolish agency and not a single word about what to replace it with, people rightfully assume you plan to abolish agency.
I hope that even after the coronavirus pandemic has passed people keep calling out the burdens to society and progress caused by the FDA.
I do hope that people notice that there are more life and death situations outside of pandemics that are, perhaps for fewer people, still very urgent. FDA regulation is often in the way of individuals getting the care they need, making decisions about life and death, and following and creating best practices in medicine.
I can understand the FDAs reluctance for home tests. They do want to make sure people aren't getting false negatives from degradation during transport. That seems like a legitimate concern.
But what I think is a greater concern, are civil rights. Several states are now giving the addresses, and sometimes names, of people who test positive for CoV-2 to law enforcement officials[0,1], and apparently health an human services used some legal gymnastics to claim that this somehow doesn't violate HIPPA[2].
You might be tempted to say "Well this situation is special," but before you do, imagine if we started doing contact tracing on people infected with HIV.
> But what I think is a greater concern, are civil rights. Several states are now giving the addresses, and sometimes names, of people who test positive for CoV-2 to law enforcement officials[0,1], and apparently health an human services used some legal gymnastics to claim that this somehow doesn't violate HIPPA[2].
100,000 deaths in the US today. Presumably there is a point at which you would see it as ok to restrict movement, contact trace and infringement on your liberty. What point would that be?
So what is the endgame again? Is it eradication? That seems completely non-feasible without truly draconian measures. If it's not eradication, if it's just "flattening the curve," that's already happened in most of the world:
Oncologists are talking about how they haven't seen new patients for two months or more. Even with clinics open, people are afraid to come in. Time is critical in some cancers. How many people will die because they've progressed to stage 2 cancers without diagnosis? How many people have already died from heart conditions because they were afraid to go to hospital. What happens when the 2nd order effects hit half of that 100,000 number?
This thing is most likely going to be a part of our environment and ecosystem. People are going to continue to die until this burns out, and that might happen before Gavi/Gates/whoever gets their vaccine through clinical trials.
So far, people have mostly been doing what has been asked, not by force. But we've been fed so much conflicting information, we are so scared and risk adverse, and our governments seek so many more powers in order to protect us, and so many people have lost their jobs, savings, businesses and livings, that there is justification for peoples' concerns.
When it comes to civil liberties, we're talking about basic rights. We're talking about the question: Who owns you?
Liberty isn't some hobby or thought experiment. Liberty is most precious in times like these, when people frame claiming one's liberty as selfishness and a threat to order.
> So what is the endgame again? Is it eradication? That seems completely non-feasible without truly draconian measures.
Eradication is the goal where I am in New Zealand. We have had 1 or 2 cases in the last week and seem on track to keep that up or improve. Restrictions are loosening fast now.
Most places do partner notification vs provider contract tracing for HIV.
Other diseases such as TB generally get contact tracing under CDC guidelines - more effective and there is less stigma.
Partner notification in some countries with high HIV rates have shown somewhat poor behavior changes and/or notification rates - but health authorities there dont trace TB or HIV regularly given limited resources
We do? I thought with HIV in the US, the patient has to voluntarily notify partners. I guess that's technically contact tracing, but does it involve health departments keeping a registry of infected individuals?
It is contract tracing. No technically modifier needed.
> the patient has to voluntarily notify partners
It is either "has to" or "voluntary" depending on state. It can be crime not to notify past partners. It can also be a crime to not warn people about your HIV positive test or otherwise put them at risk of getting it.
It is not just about degradation during transport. The samples need to be taken from deep in the throat and high up in the nasal cavity. This hurts quite badly. If the sample is taken from too low the chance on a false negative result are quite significant.
While I don't agree with the FDA on their response, it seems disingenuous that this article doesn't mention the reason why the program was shut down. It is clearly much riskier to provide individuals with their test results than to collect aggregate data. Consider for example if you gave 1 false negative, and that person then took that false negative as an excuse to return to work -- potentially infecting many more. With aggregate data a few false positives/negatives could throw off the statistics but the standards the tests need to be held to for survey purposes are certainly different than those being used for diagnostic purposes.
[1] https://scanpublichealth.org/updates/2020-05-13