Scientists baffled by decision to stop a pioneering coronavirus testing project
nature.com
nature.com
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.
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.
(1) The FDA is currently allowing some testing to continue despite the fact that they know the results are not fully accurate.
https://www.fda.gov/news-events/press-announcements/coronavi...
(2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first.
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.
>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.
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.
1. https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...
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.
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.
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.
https://news.yahoo.com/labcorp-expands-availability-home-sam...
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.
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.
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.
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.
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.
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.
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.
> In this present crisis, government is not the solution to our problem; government is the problem. - Ronald Reagan
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 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.
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.
[0] https://tennesseelookout.com/2020/05/08/health-department-gi...
[1] https://www.msn.com/en-us/news/us/most-states-sharing-corona...
[2] https://www.hhs.gov/sites/default/files/covid-19-hipaa-and-f...
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?
https://battlepenguin.com/politics/this-is-not-a-time-of-hon...
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.
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.
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
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.