Coronavirus (COVID-19)

[SwAg]

46 minutes ago, ramssuperbowl99 said:

I mean companies develop drugs with specific regulatory requirements they want to pass anyway, so it's not like this is a US-only thing.

I was more alluding to the comparative state of the U.S. pharmaceutical standards relative to our most similar counterparts: EU and Canada, which actually have higher safety standards, but lack a lot of the junk law that is pure protectionism for the industry and are only arguably related to safety (in a tertiary manner).  In fact, one of the core components of NAFTA II was solidifying US pharmaceutical protectionism from Canada.  It’s present elsewhere, but a hyper present bizarre dynamic for America.  

[ramssuperbowl99]

2 minutes ago, SwAg said:

I was more alluding to the comparative state of the U.S. pharmaceutical standards relative to our most similar counterparts: EU and Canada, which actually have higher safety standards, but lack a lot of the junk law that is pure protectionism for the industry and are only arguably related to safety (in a tertiary manner).  In fact, one of the core components of NAFTA II was solidifying US pharmaceutical protectionism from Canada.  It’s present elsewhere, but a hyper present bizarre dynamic for America.

This would be news to me, and I've worked with the OECD and FDA.

[Shanedorf]

1 hour ago, SwAg said:

Also, the spoiler version: we don’t get it.  The U.S. has outrageous protectionist policies for the pharmaceutical industry

The drug is already under clinical study in US and 40 other countries, so if it passes muster, US MDs will have access to it.
(FujiFilm is a huge company and has the global mfg capacity to meet demand if needed.)

What I think you're talking about is protection from substandard meds don't meet US FDA guidelines for safety, efficacy & Good Manufacturing Practices. ( mainly from China and India) So there was a "good" reason behind those protection policies, but Pharma industry just took it to the extreme to protect their markets $$

I'll also note that both Health Canada and EMEA ( EU version of FDA) look to US for leadership, innovation and guidance on the safety/efficacy side. Some pharma companies will go for approval in other countries first, because even though its a smaller market - its a lower bar to clear. That's on a case by case basis, but overall I'm dubious about other countries having tougher standards. I am on board with your comment that those policies have become a means to protect profits, that's exactly what happened. 

Favipiravir

Treating a homogeneous demographic like you have in Japan is very different than treating a highly heterogeneous demographic like we have here. For example - When a new drug is developed in US, Japan requires a separate clinical bridging study because different races of humans process meds differently and those differences can create toxicity. So the fact that it works well in a Japanese population may or may not mean it works for others. They're figuring that part out now
This drug is for a very specific phase in the infection -> disease progression; it shuts down the viral replication AFTER you've already been infected, but before you're fully engulfed. A worthy tool to have and it has already kept some patients from progressing/dying

Edited September 23, 2020 by Shanedorf

[SwAg]

11 minutes ago, ramssuperbowl99 said:

This would be news to me, and I've worked with the OECD and FDA.

I’ll defer to firsthand experience.  Everything I’ve read about pharmacovigilance is indicative that the E.U. set substantially similar standards, and has expanded upon those initiatives in recent years, as the U.S. reduced its standards.  But, I could be misunderstanding the comparative analyses.

[MikeT14]

Did the state of Indiana really go into full reopening? Stage 5

[SwAg]

27 minutes ago, Shanedorf said:

The drug is already under clinical study in US and 40 other countries, so if it passes muster, US MDs will have access to it.
(FujiFilm is a huge company and has the global mfg capacity to meet demand if needed.)

What I think you're talking about is protection from substandard meds don't meet US FDA guidelines for safety, efficacy & Good Manufacturing Practices.
( mainly from China and India) So there was a "good" reason behind those protection policies, but Pharma industry just took it to the extreme to protect their markets $$

I'll also note that both Health Canada and EMEA ( EU version of FDA) look to US for leadership, innovation and guidance on the safety/efficacy side.
Some pharma companies will go for approval in other countries first, because even though its a smaller market - its a lower bar to clear. That's on a case by case basis, but overall I'm dubious about other countries having tougher standards. I am on board with your comment that those policies have become a means to protect profits, that's exactly what happened. 

Favipiravir

Treating a homogeneous demographic like you have in Japan is very different than treating a highly heterogeneous demographic like we have here
For example - When a new drug is developed in US, Japan requires a separate clinical bridging study because different races of humans process meds differently and those differences can create toxicity. So the fact that it works well in a Japanese population may or may not mean it works for others.
They're figuring that part out now
This drug is for a very specific phase in the infection -> disease progression; it shuts down the viral replication AFTER you've already been infected, but before you're fully engulfed. A worthy tool to have and it has already kept some patients from progressing/dying

I’m not in disagreement with almost any of this.

I’m explicitly not using China, India, or any developing nation as a comparison, nor am I arguing against the general nature of policies restricting interstate acceptance of medicine from questionable sources.

My initial comment lacked clarity, but it’s the same point you made: as an academic exercise, many of the blights of American healthcare and medicine are fairly traceable to a particular lineage of legislation, and it was perverted to be significantly extraneous.

Edit 2 - I did not delineate specifically what I was speaking about in the legislation.  Primarily a reference to the mechanisms to avoid FTC scrutiny related to price-fixing (which was a hot subject in the aftermath of the Microsoft antitrust cases in the early 2000s that were ongoing as the legislation was under consideration), and crafting the legislation to explicitly withstand antitrust consideration under existing precedent due to de jure insulation, rather than anti-competitive practices.

The secondary comment was my understanding of comparative pharmacovigilance, and if others who are more informed on that subject say otherwise, then I have no intent to argue it.

I’m not sure what the latter portion has to do with what I said, as I explicitly compared it to the EU and Canada, which are heterogeneous populations.

Edit - Nevermind on the last paragraph.  I see the original question (that I did not answer) is related to that.

Edited September 23, 2020 by SwAg

[LETSGOBROWNIES]

2 hours ago, MikeT14 said:

Did the state of Indiana really go into full reopening? Stage 5

This is only surprising to those who’ve never been to Indiana.

[acowboys62]

18 minutes ago, LETSGOBROWNIES said:

This is only surprising to those who’ve never been to Indiana.

I once heard it described as Florida of the North...not sure if I would take it that far, but I went there once and am likely never going to have a reason to return. 

[acowboys62]

21 hours ago, Xenos said:

Two weeks and no positive cases in the NFL. What do you think is helping with this perfect streak and can it last?

For as long as the money is coming in and no one dies on the field...

[acowboys62]

On 9/21/2020 at 2:27 PM, vikesfan89 said:

Is back pain a symptom of covid?

My Dr who had it had told me he had really bad back pain and GI issues, nothing else.  I live with back pain which sucks, but stretching is your best friend (assuming there is not something damaged in there that would be made worse by the stretching).  If you end up getting a test or anything keep us posted, stay healthy. 

[LETSGOBROWNIES]

3 hours ago, acowboys62 said:

I once heard it described as Florida of the North...not sure if I would take it that far, but I went there once and am likely never going to have a reason to return. 

It’s much less diverse.

It’s Florida if you discount everything south of Tampa.

Edited September 24, 2020 by LETSGOBROWNIES

[LETSGOBROWNIES]

9 minutes ago, acowboys62 said:

For as long as the money is coming in and no one dies on the field...

This guy gets it.

[acowboys62]

2 minutes ago, LETSGOBROWNIES said:

This guy gets it.

My dad and I were talking about this yesterday.  The league that has covered up brain injuries is all of a sudden going to call out star players for this?  I would like to think they would do the right thing, but I imagine they wouldn't.  I do hope as a fan everyone stays healthy because 1) this is just a game at the end of the day and 2 if they really try to keep things quiet and it ends up in a bad outbreak, it is going to look really fricken bad for the entire brand.  I assume the protocols in place are all being run by independent third parties? 

[MWil23]

5 minutes ago, acowboys62 said:

I assume the protocols in place are all being run by independent third parties? 

[pwny]

Did these ever get posted?

https://aatishb.com/maskmath/