41–50 of 61 posts
I can see an arguement to "try anything" in an emergency. But how did the fda end up being BOTH to lose and too tight with their regulation?
Earlier quoted context omitted.
There’s no reason to play partisan politics here. If we want we can say Democrats were too busy trying to impeach Trump and calling Wuhan a “manufactured crisis” back when Trump ordered the borders closed Jan 30. The simple fact is non-partisan non-evil, simply incompetent bureaucrats at the State and Federal levels all failed to adequately prepare (PPE stockpiles) and had actively harmful policies set in place years…
So you are equating democratic legislators taking part in the impeachment hearings to the trump administration dismantling the CDC pandemic response team? Let's not even get into the "corona will just disappear... or it's just like the flu..." These arguments about "let's not make this a partisan issue" completely ignores the reality. The same about how news and politics are so divisive at the moment, yes they are bu…
> literally said people carrying swastikas are very fine people as well.
Trump, several seconds later [0]: "And you had people -- and I’m not talking about the neo-Nazis and the white nationalists -- because they should be condemned totally. But you had many people in that group other than neo-Nazis and white nationalists. Okay?"
[0] https://www.politifact.com/article/2019/apr/26/context-trump...
There are number of conflated regulatory problems in this piece: 1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020 2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make…
Also: "In 2015, FDA established an Interagency Task Force on LDT Quality Requirements with CMS, the Center for Disease Control and Prevention, and the National Institutes of Health"
Any manager worth his/her salt can tell you that a task force involving four different agencies is unlikely to ever result in any meaningful change. A cornerstone of effective management is to designate one person who is responsible for execution and hold them accountable. This is exactly how the executive branch, from the president on down, is supposed to function (with oversight from the judicial and legislative branches, of course), but few parts of it are like that after centuries of bolting on overlapping agencies and departments.
Earlier quoted context omitted.
I think the Europeans Medicine Agency is a model for making sensible tradeoffs here, at least compared to the FDA. I sort of with the US could just outsource drug approval to them.
The EMA is? The EMA typically takes longer on average to approve a drug than the FDA.[1] And if you want to look up an EU scandal, check out the Servier and Mediator. Hundreds of deaths reports and it took France almost 20 years to pull it off the market.[2] [1] https://news.yale.edu/2017/04/05/fda-approves-drugs-more-qui... [2] https://www.fiercepharma.com/pharma/servier-faces-courtroom-... .
1. Approve something too soon. This kills/hurts patients using it.
2. Wait too long approving something. This kills/hurts sick people who are deprived of good treatment.
The classic big FDA flaw is to heavily lean towards type 2 errors, because type 1 deaths lead to bad PR, while no one notices type 2 errors.
So that EMA apparently made a type 1 error here is possibly a good sign!
Earlier quoted context omitted.
There were some great drugs that were blocked because it raised blood pressure slightly :/
Higher blood pressure is linked to increased mortality. It's not like they are blocking the drug for fun.
There are number of conflated regulatory problems in this piece: 1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020 2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make…
Thing about these problems (and others) is that bottle necks and red tape generally are problems in just about any country. Political leadership in this situation involves noting the regulatory and bureaucratic hurdles to action and using your authority to supersede them when a pressing situation requires it. Someone has to sit down and say "what needs to happen, what's standing in its way? What orders have to be iss…
I still don’t understand why the FDA was telling labs not to develop their own tests. After publication of the primers, it’s standard work to create an rtPCR. And being a lab developed test it should be out of the jurisdiction of the FDA.
Earlier quoted context omitted.
There were some great drugs that were blocked because it raised blood pressure slightly :/
Higher blood pressure is linked to increased mortality. It's not like they are blocking the drug for fun.