I'm not clear how it returns results so quickly. I thought that the RT-PCR process required numerous heating and cooling cycles which is what makes it take as long as it does.
I looked at their one of their patents and it looks like they might be using something like rolling circle amplification instead of traditional amplification techniques for faster speed (I don't know off sure but it's one of the options in their claims). Kind of like LAMP pcr where you can amplify really quickly to get a signal really rapidly (although the dna at the end isn't really useable for further synthetic biology - it just provides a strong signal). They also mention a couple other types in this patent like strand displacement etc, so there's a lot of options they could be using.
Edit: the keyword to look for might be "isothermal" amplification, which means same - temperature amplification. Again, no clue if that's what they're using, I just see that they have patents on using isothermal techniques. These allow for amplifying DNA without cycling the temperature, usually letting the reaction accelerate quickly until a signal is detected, and it can accelerate really quickly sometimes. You know those videos of supercooled liquid water where you bump the bottle and the whole thing freezes? Imagine that you have a situation like that where adding non-coronavirus dna bumps the bottle incorrectly and nothing happens, while adding coronavirus dna makes the whole thing freezes. It's a rapid signal that just gets generated, but often (like with lamp) you just end up with a polymerizated mess that you can't use for DNA engineering in synthetic biology which is why you might use your temp. cycling methods for those uses. Also, they're good for telling you if something is or isn't there, but not so good at telling you how much dna you started with. To figure that out you again use a cycling reaction with the amount of dna doubling each step until it levels out so you know how many doublings happened and can calculate backwards (quantitative rt-pcr, or qPCR).
Thanks! I was trying to find a universally known example or party trick of something just polymerizing quickly,which I couldn't think of, so went freezing instead (since it looks line if like polymerizing? And I think lots of people have seen those videos showing off that trick). If you want clear, beautiful ice, you've gotta freeze it the right way. But if you want to know if water is cold enough to freeze and don't care about using the ice, bump the supercooled bottle. Trying to convey the differences in constraints between a) detecting dna, where it's a destructive test for all intents and purposes since the end product is just tossed into biohazard - you just wants signal and b) making more usable dna for further research, where you want that end product for further manipulation and so has to high quality, usable dna, not just a polymerized mess. Lots of rapid PCR diagnostics take advantage of this to use gunk-creating rapid tests while scientists working on engineering the same DNA will use temperature cycling processes to clone the DNA and do work on it - each has its use.
It's worth nothing that this machine is very low throughput - the larger one only takes 4 samples and you have to use their proprietary disposable cartridges.
edit: as pointed out below - the largest of the machines has 80 slots and could probably do 2000/day taking around 45min-1hr/test all in
Contrast that with a modern real-time PCR machine which typically has capacity for 96 samples, with some machines able to test 384 or even 1536 at a time. The tradeoff is that those machines take 2-3 hours and the lab needs to do nucleic acid extraction separately.
The main advantage of this machine is that it does the nucleic acid extraction and PCR in one cartridge and in ~20 minutes. It's great for clinics and field hospitals but for an established laboratory running hundreds or thousands of tests per day, I'd wager that the standard methods are much cheaper and a bit faster overall.
It's pretty neat-- they have 1, 2, 4, or 16 slot things that you can slot samples into as you're ready, and they process in the background... or the big robot. It's also neat in that they have combined cartridges to do a couple of influenza detections + RSV in one rapid test (with a different color of fluorescence for each).
But you're spot on in that this has a costly consumable (the cartridge)
PCR tends to have pretty low false positive rates if used properly - so from a technology perspective the contribution to that would be low. Although, if they're using more innovative PCR methods, maybe there's a risk.
Where I think there's room for them to introduce false positive rates (that we would not know without having access to proprietary information) is in how they design something called a primer sequence. this is a little bit of DNA that will go and find to a different little bit of DNA that's part of a larger bit of DNA. Basically it lets you target it a little bit of DNA within a larger bit of DNA. you want to make this primer so that it only will bind to coronavirus DNA but will not bind to any other DNA. It's important to design it that way because in PCR the DNA that amplifies to give you the signal is whatever that primer was able to bind it to.
If you accidentally make a primer that can bind to some non coronavirus DNA (something we call off Target binding) then you would end up with false positives. There are bioinformatics tools to evaluate this and presumably the FDA and the company did some work into making sure they didn't make any mistakes when designing that, but that's what I think of first when it comes to false positives.
PCR tends to have great specificity and great in vitro sensitivity. The sensitivity drops off with pre-analytic errors that accumulate in real world testing (wrong collection method, wrong media, wrong swab, etc). So false negatives are the problem.
The nice thing is that it catches acute infections even earlier than IgM.
The fast turnaround time is from integrated sample prep and reagent cartridge. It just uses standard thermocycling PCR. PCR doesn't take long when volume is small and heating surface is large.
I don't think that's going to work because this is a fairly complicated machine, and the company itself which has experience building molecular testing equipment and has a manufacturing supply chain in place is one of the only few that can build this.
Also asking them to open-source their technology seems unfair, they're entitled to their share of pay for their hard work. The average engineer at this company probably makes much less than the average engineer at your FAANG company.
What - are they couriering the money from a secure vault in Germany by barge, horse and carriage? I think not. It'd take a day or so to negotiate and then a few hours of banking transfers. Governments around the world are currently engaging in multi-billion to potentially multi-trillion dollar emergency spending programs. There is room for negotiation and cash up front while the company holds all the cards.
It isn't a good idea to fight economics in this crisis; beyond cushioning people in the very short term against quarantines. It will leave everyone in a very uncomfortable place if the incentives push individuals to avoid helping in the next crisis. Or worse; avoiding the entire field. The problem with all these 'experts should give away this lifesaving X for free' ideas is that then only an idiot would try to become a medical expert - anyone smart would try to go to Wall Street where they are allowed to make crazy profits.
The people working on this stuff are doing an insane amount of good. If there aren't a few billionaires minted in the medical community out of this something has gone terribly wrong - the incentives aren't there to guide resources towards preparedness.
If you seize someone's company every time they have a worthwhile breakthrough, that's really going to put a damper on working on problems like this. Not only would you be toiling for uncertain/small reward, you might be flushing your entire business down the toilet.
Also, you seize the company-- then what? Are you going to be able to ramp up production, etc, as well as the original product group could? Are you going to make them work on it at gunpoint?
I agree there's a good point to this. At the same time I dislike and disbelieve the capitalist narrative that the deepest motivation is the profit one.
It's not that the deepest motivation is the profit one. It's that it's the best at bringing together large scale consistent cooperative teams. When you have a profit motive, you don't need to convince every single necessary person or resource provider to believe in your mission, you just have to pay them. And that makes a lot of things possible that wouldn't otherwise be.
Oh yah, that makes a lot of sense. /s IF you succeed, you get upside bounded at +20%, but you still have full downside risk. And of course, most things in bio R&D don't work.
Also, re: your other hyperbole point-- this test system is neat and fills a small gap in testing capabilities. It does not have the ability to "save millions of lives" but could be a nice tool among many to help slow things down. It doesn't scale well, so it's not how you'll do most tests, but there are scenarios where having a close-to-immediate result noticeably helps.
> Show me another breakthrough in the past 100 years that could save millions of lives ...
The past century is littered with thousands of examples of technologies that have contributed in this or bigger ways. The Rosch and Abbott machines are going to be the workhorses here, not the Cepheid ones.
* "Making" 20% if you happen to be successful, when most efforts fail, is not much of a prize-- especially if you lose your company in the process. Not even the most diehard gambler would play slots with those rules. ;)
* It's not going to save millions of lives. There's lots of tests available meeting different needs. It may save some lives, and will likely improve quality of life of those suspected of having COVID-19 quite a bit.
Identifying and quarantining is a complicated strategy and this test is not going to be the "workhorse" of it and is certainly not going to save millions of lives. Look to Rosch, Abbott, and others that have made pieces of already-deployed infrastructure to fill that need.
20% for a few months worth of effort is more than fair. They would not lose the entire company, simply the rights to the specific technology. And, even if it is "the whole company," then they can go start another one, or go cry me a fucking river. You seem to think I care; I don't.
Mass testing literally will save lives. It worked in South Korea. If we could run 700M tests (slightly more than 2 per US resident, because you have to run at least 2 as an accuracy check) right now, I guarantee you we could get this under control.
Don't believe me? Believe this guy. He's a doctor:
> Testing, Testing, Testing: We must widely test our population, diagnose mild and even asymptomatic cases. Requires point of care diagnostics in doctor's office. We must advance these immediately to market. It means serology to know who was exposed and developed immunity. 9/n
But, every incremental step helps here. Information is literally our only weapon against this disease right now, and testing is how you get that. Getting something like this into the hands of doctors on the front line right now is what is needed.
> 20% for a few months worth of effort is more than fair. They would not lose the entire company, simply the rights to the specific technology. And, even if it is "the whole company," then they can go start another one, or go cry me a fucking river. You seem to think I care; I don't.
The rapid test technology is something that Cepheid has been developing since before 2010. Now they have gotten approval to load reagents into the disposable cartridges their machine uses to test for COVID-19. There is no way to parcel off "just this test".
> Mass testing literally will save lives. It worked in South Korea. If we could run 700M tests
The Cepheid technology, as I've been patiently explaining to you, is about the dumbest way to run millions of tests.
The Cepheid test costs about $40 in raw materials, when a similar test from Roche has an underlying cost of $0.75, but it requires a much lower degree of operator skill and capital equipment. But because it requires less operator skill and less capital equipment, it can be closer to patients, especially in remote areas.
But you're too much into "rah rah let's nationalize the technology" before you even realize what it's useful for. Neat.
Okay, it's been in development for 10 years? 20% per year, then. Done. A 200% return over 10 years is a CAGR of 11.61%, just a hair lower than what you'd get dumping it all into an S&P 500 index fund on 2010-01-01 and cashing out 2019-12-31, plus you get to put "saved millions of lives" on your resume. Totally fair.
You don't think the US government can afford $80 ($40x2, because you should run 2 tests for confirmation) to test every resident of the country? Google tells me there are 327.2M people in the US. $80/person is only $26 billion. How much are we spending again on useless foreign wars that nobody questions? How much did the Fed spend in a failed effort to stabilize the market a couple weeks ago?
You also forgot, this test returns results in 45 minutes, whereas the other version takes hours. Reducing the time to result by an order of magnitude means you can test an order of magnitude more people. You said it right here: "... it requires a much lower degree of operator skill and capital equipment. But because it requires less operator skill and less capital equipment, it can be closer to patients, especially in remote areas."
So, what do you want, $26 billion in the US treasury, or every single human inside the US borders to be tested for coronavirus? Granted, that testing will not happen instantaneously, but it will happen far, far faster with this technology deployed at scale than not. And, I don't see Cephid moving to put 10 of these in every hospital in the country yet. Do you?
Let me put it to you another way: do you want to go the way South Korea has, or the way Italy has?
I want to use the machines that are built for high volume testing, and not try to ramp up production of a cost-inefficient cartridge thing for the bulk of testing that we could never get enough tests from in a reasonable time. (Takes a week+ to make tooling for injection molding even on an expedited basis and I guarantee you they cannot produce enough of these fancy plastic cartridges to test everyone with present tooling).
Of course, I also want to take advantage of the unique capabilities of the cartridge based system where they're most useful.
This is mostly because I'm not stupid. Neither is South Korea; they're getting fine just by with traditional, cost-efficient RT-PCR practices.
Instead of open-sourcing, shouldn't we just give them as much funding as possible to manufacture as quickly as possible? This isn't software. You can't just `git clone` their repo, and random indie hackers 3D printing things that seem to work might do more harm than good.
Open Source is probably not the right model - because this gear is very complicated, only a few entities can possibly be involved.
The 'best software in the world' is often written by some dude, at home, working when he wants, possibly in his pajamas, possibly collaborating interactively with other people.
Software often does not need experience or teams, just intelligence, creativity, assertion. Although experience helps.
This kind of gear, or anything physical really, 100% requires the experience of various kinds.
If we had a really competent industrial board that understood medical technology, we could feasibly put together a kind of 'shared IP' contract very quickly.
Bidders could be quickly approved, sign up, get the plans, and start making according to specific terms.
Just because we're in a panic doesn't mean there can't be standards & controls - they just have to be rapid and risk-adjusted.
It could be a win-win-win even in a time of the pandemic.
I have little faith in our governmental leaders for the most part. It's not that they're not smart, it's that I don't think they generally have operational wherewithal to make decisions, push stuff through in such a crude and cold manner. Surely they are some, but you need a critical mass of them, and political backing as well.
1) there’s going to be a ton of point of care tests, in fact there already are. The bottleneck is FDA approval.
2) scaling up manufacturing of a device like this is HARD. It’s not some raspberry pi hobby kit.
This company is owned by Danaher, a fortune 200 or so which has many engineers and manufacturing sites. They’ll figure out a way to make as many as are needed.
"Hey guys, thanks for working on this thing that's really useful during this unexpected pandemic, great you were working on that while nobody else was paying any attention. We're just going to steal it now and give it away for free, kthxbye."
FDA is remarkably quick to authorize things like this test that will make the epidemic look worse, and yet are somehow utterly unwilling to consider authorizing the treatments that have been shown to be effective.
If you mean a machine to automate medical tests, yes. But there are plenty of companies that already make such machines. If you mean a machine to run every possible test using only a few drops of blood, no.
> Where are the 5000/day (hour?) machines doing it for $1 a test?
This fills a different need. Rosch has their tests to market and test quantity is ramping up at designated centers. $1/test is just what Rosch gets, so it's gonna cost more than that.
> It was a matter of automated diagnostic reprogramming?
Nah, you still need reagents.
> So this is promised in 10 days. How many units, 15000?
The Cepheid machines are neat. They make bigger machines, but mostly you buy a machine with 1-8 slots and disposable testing cartridges. When a patient needs a test, you put their sample in the cartridge, stick it in a slot, and that slot yields an answer in 45 minutes.
This will be a very nice tool for individual, smaller hospitals (and even large clinics) to have in the next 10 days when it rolls out, and for situations where we want to get immediate feedback. Probably not a massive number of units at first. And not nearly as cost-effective as the Rosch.
There's not a single person who would agree that the US president is handling this well - For purposes of discussion of COVID19 it's best to just ignore him (I mean this respectfully but seriously).
This is ~13% (absolute) more than his approval rating, so a big chunk of people think his is handling this well.
That said, the GOP thinks this will impact his chance of reelection. Steve Bannon said "he's not running against Joe Biden, he’s running against a virus and the collateral damage from that." So far, the states in lockdown mode where deaths and job losses are likely were going to vote Biden anyway. If more rural states start having problems, expect a lot of swing states to swing left.
I don't know the name of it, but there's a tick psychological tests do where they reverse questions, hoping to see if people are answering honestly. There was a window where most people approved of the ACA and disapproved of Obamacare.
Keep in mind that all of the data in polls comes from the type of people who respond to random polling with something other than hanging up. I'll admit, I may suffer from the mother of all sampling biases but in the social circles I frequent this is not at all a common trait.
Yet these same polls keep accurately predicting primary results on a similar small scale.
What we need is more of them and wider samples to reduce the ~95% error rate of the ABC results even lower. Not critiquing ones who have a well established reputation for following good methodology, as if polling never has value (FiveThirtyEight has litigated this to death and have largely won the argument).
Telling the truth ("anybody that needs a test gets a test"), taking responsibility ("I don't take responsibility at all [for the lack of testing]"), making tough calls instead of leaving states and cities to fend for their own.
And the switch from "this is a hoax" to "I always knew this was a pandemic" doesn't inspire confidence either.
Activating core engineers to build field offices which they are trained to do. Getting factories to build paper masks for the public. Getting the car manufactures to build ventilators. Getting money and supplies to the hospitals. Activating the reserves to setup drive through testing in every major city.
> Is this sarcasm? This is exactly what is happening.
I think this is what is said to be happening in press releases, but not occurring in fact (at least according to the governors who should be the beneficiaries of these acts)
Look, I don't like Trump, I didn't vote for him, but it takes a pretty ridiculous warping of reality to say that he isn't taking this extremely seriously, isn't deferring to experts on this, and honestly isn't doing a pretty good job.
What more do people want? I wish we had a time machine and could go back to November, I'm sure everybody does. But we don't. What matters is what we're doing RIGHT NOW, and right now the things that I see happening all seem like good things.
Have you watched any of the press conferences? That is exactly what he is doing. Drs Fauci, Burks, and Adams give lengthy addresses every day (although Burks and Adams were not present today), as well as answer questions from the press. Trump seems to be deferring to them pretty heavily in the question parts as well.
As far as having the spotlight: Dr. Fauci has basically become a household name amongst my peer group. He absolutely has the spotlight.
edit: could the people downvoting this please at least leave a comment?
Activating the DLA (Defense Logistics Agency) to handle supply control and distribution instead of this states vs. states and states vs. fed gangbang of bidding and suboptimal routing of resources that's going on right now.
I would say that the media’s reporting of the crisis has simply continued to show people that their coverage of the president is just hysterical nonsense. Those who have drunk the koolaid will continue to lap it up though.
Because it's hard to know if he's joking since he constantly peddles conspiracy theories like birtherism and keeps company with people like alex jones who are serious about things like sandy hook never happening.
No, if you actually listen to him it's pretty obvious that he is joking. The general idea that we have unelected bureaucrats that some people think have too much power in our government is not the joke. Calling the State Department the Deep State Department is the joke.
"I am fighting the Fake (Corrupt) News, the Deep State, the Democrats, and the few remaining Republicans In Name Only (RINOS, who are on mouth to mouth resuscitation), with the help of some truly great Republicans, and others. We are Winning big (150th Federal Judge this week)!"
It's only a joke because the concept is absurd. Like if he referred to lizard people, I'd know it's a joke. Except he actually believes in a deep state, so for him it's not a joke.
I guess it depends on whether you read the headlines that say “Trump calls State Department ‘Deep State Department’”, or whether you read the actual quote.
> I'd like him to go back to the State Department or as they call it, 'the deep state department’.
It’s frankly ridiculous to think this wasn’t a joke, regardless of how unfunny you think it is. It’s also very hilarious that this thread has moved on from “There's not a single person who would agree that the US president is handling this well”, to “but what about that joke he made!!!”. When people see that the most voracious criticism of Trump often turns out to simply be humourless outrage mongering, I’d wager it helps his image, if it had any impact on it at all.
It took me two minutes of lazy searching to find a video - and I want to emphasize that I am seeing it as is, it's not editorial or article covered by CNN - where Stephen Miller, a senior white house advisor seriously uses the words "deep-state" to refer to sinister efforts to undermine this president.
Trump and his cohorts really believe there's a deep state - it's not a joke for him.
On a slightly related note, it's frankly scary how much people twist things to see what they want to see. I sometimes wonder how much worse the situation would be if someone more nefarious and competent were in power. It wouldn't be as easy to just pull up a video like this, and much harder to disprove "it's just a joke dude".
Well you’ve moved the goalposts quite a bit here (by now tremendously far away from “There's not a single person who would agree that the US president is handling this well”). Trump jokingly referred to the state department as the deep state department. Quite different from the accusation that he seriously referred to it as a department solely responsible for deep state operations. This was so obviously a joke to anybody except those willing to take even the most spurious opportunities to criticise him for anything.
The question of whether there’s one or more groups of unelected bureaucrats working to undermine and obstruct his presidency is an entirely seperate matter. The answer to that question is also demonstrably and unequivocally yes. This was proven without doubt when the OIG released their report detailing a laundry list of illegal FISA abuses that were used to spy on his campaign, by the fact that the mueller investigation, which served no purpose other than to obstruct his presidency, came up with absolutely nothing, and by the travesty of the impeachment “inquiry”. Just to name a few instances.
> Well you’ve moved the goalposts quite a bit here (by now tremendously far away from “There's not a single person who would agree that the US president is handling this well”).
This might make sense if I said this. I did not.
> This was so obviously a joke to anybody except those willing to take even the most spurious opportunities to criticise him for anything.
Again, not really much of a joke if he actually believes it.
This is interesting. The same poster also moved the goalpost in a response to one of my comments. I hadn't yet read your comment, but also responded by noting the goalpost movement. The sad thing is, I had already clarified in my own post the difference between making a deep state reference in general, and this specific and obvious joke.
When I watch his speeches (which is rare, because it makes me a little ill), I watch them unedited. I don't watch the news at all, I find it just as gross. I have been watching his speeches as they relate to the pandemic because I want to know when we're going to switch from "OMG shut it all down" to "Here are the steps we are taking to get out of this."
I understand it's hard to see when you are very partisan, but not all of us see everything through a left/right filter. I just want the facts (as close as is possible).
I dream that in post-crisis clarity, some news sources will reverse the traditional "FDA as protagonist" wording of such headlines, and instead prefer formulations like:
"FDA removes threats of fines & imprisonment for one company's point-of-care COVID-19 diagnostic"
The FDA has no role in creating this test – or any other. They've just dangled a threat of prosecution over companies, hospitals, research labs, and universities who wanted to develop & use a variety of tests – including tests that have proven very useful elsewhere.
When they "authorize" something, all they've really done is removed the prior threat of fines & imprisonment. This threat exists even if the thing they're holding up had little to no risk of harm or confusing anyone. (People, especially those in research labs and the medical profession, are not idiots! Even all sorts of long-approved diagnostic tests have significant errors associated that doctors & patients need to discuss & account for!
This administrative-law threat exists even if traditional product liability – as applies for all sorts of other product/service/info-product category – would be more than sufficient to ensure quality, & punish recklessness.
The FDA's delays have held back US testing capacity for months. The current economic disaster, & many deaths, are a direct outgrowth of both the legislation which gives them this veto-power, and their incompetent exercise of the various discretionary powers they have. They could have offered the same arbitrary waiver that they finally did, on February 29, back in last December!
Even now, urgently needed medical supplies are held up, waiting for FDA inspection/certification backlogs to clear:
The FDA shouldn't get to tout themselves as doing a good thing with this "authorization" – when the risk of harm of such vitally-necessary new testing options is so small that a delay of days, much less months, is unwarranted. Let scientists, doctors, & patients experiment!
People fear that without some oversight, dangerous things would be sold
Yet they go to the local restaurant who's preparing dishes with no special oversight ex ante, just good logic and the fear of being closed if there's an hygiene investigation ex post.
For some reason, reviews can filter out bad restaurants but not drugs? Even if food can also kill? Evidence of the opposite, from darknet markets where people review drugs and sellers, is routinely ignored.
But when the CDC delivers a non working test, people want more money for the CDC- so that next time, they don't deliver one non working test, but maybe 2 or 3 instead?
My personal conclusion is that the "modern hacker" trust centralization and likes social control - whether it comes from government organizations, or private companies like google or facebook. Based on comments, working there would be a dream from most people here - and not just for the money. People seem to find some kind of prestige in that, for... reasons?
There's a generational disconnect I think. I stopped trying to understand. When I see a movement pushing away Eric Raymond and Richard Stallman, I think it's time to stop associating with this movement, let these people make their own mistakes and hopefully learn from their failures.
>Yet they go to the local restaurant who's preparing dishes with no special oversight ex ante, just good logic and the fear of being closed if there's an hygiene investigation ex post.
Yes, because there are health and safety regulations in place!
Their doctor has a choice - or should, & could with fewer barriers to competition, especially barriers against things which work just fine throughout the world.
The free market absolutely has the capability to control for snake-oil salesman; that is why there is a large and profitable business in reviewing items.
In America the CDC was distributing snake oil in this crisis, their test kits didn't work. As the death toll rises that is going to enter free-marketing lore as a classic example of government regulation contributing to a crisis. There should have been 10 free market solutions and a CDC endorsement for the one they liked best. Depending on how this plays out we may well discover that lighter regulation would have saved literally millions of lives.
Notice that as soon as a crisis hits and the government needs someone to figure out a solution their first and only tool is removing regulation. This is a powerful hint - that regulation is also retarding useful action in non-global-pandemic crisises.
There is a giant market for fake mattress reviews and a tiny market for real ones. You see the same basic paradigm across a range of industries where reviewers make more money from advertising deals than their customers. That or just early access only being handed to people with positive relationships resulting in a lot of bias.
Net result, consumer reports maintained a solid reputation over time and most independents end up selling out at some point. Well that and several billion dollar snake oil companies.
PS: Fill in the blank: The water cooled ultra X get’s an extra 2 FPS ___ . (meh save yor money.) or (which is so amazing!)
The medical & scientific professionals who order – & desperately need! – new tests aren't laypeople sifting through online mattress reviews.
They are experts, who can compare results in real cases, learn what's working, and then share their experiences – in their small, real-names, real-reputations communities – with others.
And the tests that have been blocked aren't being developed by fly-by-night hucksters who ride a horse-drawn cart into town, then disappear into the night before their trickery is revealed. They're by existing medical/biotech/scientific giants – who are already supplying the same doctors/hospitals other trusted diagnostics, or supplying the exact same tests around the world with strong track records.
If you think the fake-mattress-reviews issue is a major one, by all means, get a "Federal Mattress Agency" to save the poor consumers. But let doctors/hospitals/scientists develop, and try, new things without months/years of delay on low-risk products.
Theranos is a recent example of medical professionals being fooled by exactly that kind of hucksters. Without regulation I assume the situation would deteriorate significantly as the risks of being sued would still exist but be irrelevant for people who took the money and ran.
As far as I understand Theranos actually bled money to provide correct results through traditional testing methods while it pretended to use its own devices. Given that Theranos was basically a black box to any outside observer medical professionals only saw that they had something that obviously worked. Other than violating various lab regulations it mostly defrauded investors while still providing the service it was paid for. If it gets bad enough I think having a few investors defrauded is an acceptable risk.
> regulation is also retarding useful action in non-global-pandemic crisises
This is a given, and doesn't mean it's not worth the tradeoffs. We shouldn't have a system that is always adapted to be ready for global pandemics, because most of the time, we don't have one. If we didn't need to change anything, it probably meant we were making poor tradeoffs in peace time.
Like credit rating agencies and how well they work? /s
In this case, it's not even about falsely marking up poorly understood investment products for extra business, it's people's health.
Any reviewing businesses that are strict with their criteria simply won't get business from device companies, all we've succeeded in doing here is moving the problem up one level.
My take is that we need to strive for effective regulation (so I'm not coming at this from a 'government is always the problem' perspective, just thinking out loud).
There is some incentive for medical providers and insurers to use safe and effective treatments (good reputation is good business). For products that are not immediately physically dangerous, perhaps retrospectively evaluating their choices would be similarly effective for outcomes as the current approach of banning things until they are approved.
This is an interesting perspective, especially in the context of our current concerns over the balance between emergency commerce restrictions and potential.
Do you think that we would have been better off with letting the market itself make more decisions regarding what should stay open during the crisis?
That makes no sense. Selling snake oil to sick people results in, among other possible side effects, dead snake oil customers. That's a historical fact, which is why there is regulation.
Even the former chairman of the FDA admits that the FDA is the main reason why the US doesn't have enough coronavirus tests.[1]
If not for the FDA we would have ramped up testing 6 weeks earlier. Labs were already developing and doing their own tests in January, but the FDA clamped down on them and forced them spend weeks jumping through bureaucratic hoops.[2] The only test approved by the FDA was one made by the CDC, which turned out to not work due to a bad batch of reagents.
The FDA is also the biggest reason why EpiPens cost so much[3], why a drug company can increase the price of Daraprim 50x without worrying about being undercut by competitors[4], and why there is no generic insulin in the US[5] (despite the molecule being off-patent because it was discovered a century ago). These regulations are killing thousands of Americans every year.
Brochure (pdf) - https://p.widencdn.net/jdgicj/Cepheid-GeneXpert-Xpress-Syste...
Promo video - https://www.youtube.com/watch?v=lPTHRqDyWC4
About the size of a small laser printer.
I'm not clear how it returns results so quickly. I thought that the RT-PCR process required numerous heating and cooling cycles which is what makes it take as long as it does.