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(09-03-2020 01:15 PM)BlazerMatt Wrote:  By skipping phase 3 trials which is irresponsible as hell and is going to get a lot of people killed.

That doesn’t matter as long as a vaccine is available before November 3, 2020.

(09-03-2020 01:15 PM)BlazerMatt Wrote:  By skipping phase 3 trials which is irresponsible as hell and is going to get a lot of people killed.

Might get people killed, not will. Might kill a lot of people, might kill a few, might not kill any.

73% of drugs approved in the U.S. in 2018 were fast tracked, skipping phase three trials. So it's, just not that uncommon these days.

Not saying that it's a good or responsible thing, just that's the way it is now.

https://www.wsj.com/articles/fast-track-...1562337924

(09-03-2020 03:44 PM)blazerjay Wrote:  

(09-03-2020 01:15 PM)BlazerMatt Wrote:  By skipping phase 3 trials which is irresponsible as hell and is going to get a lot of people killed.

Might get people killed, not will. Might kill a lot of people, might kill a few, might not kill any.

73% of drugs approved in the U.S. in 2018 were fast tracked, skipping phase three trials. So it's, just not that uncommon these days.

Not saying that it's a good or responsible thing, just that's the way it is now.

https://www.wsj.com/articles/fast-track-...1562337924

I think it’s more likely to have adverse side effects that fall short of death. It more likely a lot of people will be unwilling to take untested vaccines and some will get sick and die as a result.

I am a big believer in vaccines. I have administered literally thousands.

There is no way in hell that I jump on a Covid vaccine that has been rushed simply so that there will be one out before election day. Note that this is coming from someone with an immune impaired wife. No effin' way, y'all.

(09-03-2020 01:15 PM)BlazerMatt Wrote:  By skipping phase 3 trials which is irresponsible as hell and is going to get a lot of people killed.

Aren't several vaccines in phase 3 now? It seems a few started in late July/early August.

This is how clinical trials work.

Phase 1
Does this drug treatment meet the minimum safety stands to test on humans. Usually takes a few months and involved a small number of people, less than 100 usually. Because they are testing for safety, they generally only test it on healthy volunteers.

Phase 2
For the first time you start looking at how effective the treatment is in a double blind study where usually 66% of your test subjects are getting the treatment and the remainder are getting a placebo. You are testing on sick people now, so you want the therapy to be given to as high a percentage as you can while still having a statistically significant control group. This stage can last anywhere from a few months to a couple of years and usually involves 300-500 test subjects. Just 30% of drugs make it past phase two either because they don't work or because they have dangerous side effects.

Phase 3
Once you have a treatment that has shown to be effective, you enter a phase three trial. Is it safe. Is it safe for men, women, pregnant women. kids. Does it have crazy interactions with other medication, including commonly used over the counter medications. As in phase two, you are testing on people who have the condition you are treating,but there are so many more variables you are testing for now you need many more volunteers and MUCH more time. Phase 3 trials usually last from 18 months to four years. Less than 30% of drugs that have made it this far survive phase 3 testing.

Phase 4
Ok, you have a medicine that seems to work in the short term. Seems to be safe in the short term. Seems to have an acceptable number and severity of side effects and adverse drug interactions in the short term. So now its time to track long term effects from a large population of people who have been receiving the treatment. Phase 4 involves thousands of people and lots of time. Skipping phase 4 is where we get a bunch of grim dystopian novels by the way. The book you read where there was some disease and the treatment wasn't tested properly and turned everyone into zombies, or made them sterile or caused everyone to become hyper aggressive and start killing each other, thats the fantasy version of skipping phase 4. The reality is that skipping or rushing phase four results in all of the commercials you see and hear from lawyers about how "XYZ has been recalled and has been proven to cause death or injury in people who used it. If you or a loved one have taken xyz in the past, call me at 1-800-I-SUE-NOW"

Whats happening now is that we are suggesting to rush through Phase 3 so quickly as to make it meaningless, and make the entire population of the US the subject of Phase 4.

(09-04-2020 09:35 AM)BlazerMatt Wrote:  This is how clinical trials work.

Phase 1
Does this drug treatment meet the minimum safety stands to test on humans. Usually takes a few months and involved a small number of people, less than 100 usually. Because they are testing for safety, they generally only test it on healthy volunteers.

Phase 2
For the first time you start looking at how effective the treatment is in a double blind study where usually 66% of your test subjects are getting the treatment and the remainder are getting a placebo. You are testing on sick people now, so you want the therapy to be given to as high a percentage as you can while still having a statistically significant control group. This stage can last anywhere from a few months to a couple of years and usually involves 300-500 test subjects. Just 30% of drugs make it past phase two either because they don't work or because they have dangerous side effects.

Phase 3
Once you have a treatment that has shown to be effective, you enter a phase three trial. Is it safe. Is it safe for men, women, pregnant women. kids. Does it have crazy interactions with other medication, including commonly used over the counter medications. As in phase two, you are testing on people who have the condition you are treating,but there are so many more variables you are testing for now you need many more volunteers and MUCH more time. Phase 3 trials usually last from 18 months to four years. Less than 30% of drugs that have made it this far survive phase 3 testing.

Phase 4
Ok, you have a medicine that seems to work in the short term. Seems to be safe in the short term. Seems to have an acceptable number and severity of side effects and adverse drug interactions in the short term. So now its time to track long term effects from a large population of people who have been receiving the treatment. Phase 4 involves thousands of people and lots of time. Skipping phase 4 is where we get a bunch of grim dystopian novels by the way. The book you read where there was some disease and the treatment wasn't tested properly and turned everyone into zombies, or made them sterile or caused everyone to become hyper aggressive and start killing each other, thats the fantasy version of skipping phase 4. The reality is that skipping or rushing phase four results in all of the commercials you see and hear from lawyers about how "XYZ has been recalled and has been proven to cause death or injury in people who used it. If you or a loved one have taken xyz in the past, call me at 1-800-I-SUE-NOW"

Whats happening now is that we are suggesting to rush through Phase 3 so quickly as to make it meaningless, and make the entire population of the US the subject of Phase 4.

My sister was a victim of side affects of a drug given to pregnant women in the late fifties to early sixties. She was born with a hole in her heart and was totally pacemaker dependent. The most infamous of all, thalidomide, was sold as a remedy for morning sickness. Everyone complains about needless regulation slowing down progress. If you child is born with flippers instead of arms you understand some regulation is needed

(09-03-2020 03:44 PM)blazerjay Wrote:  Might get people killed, not will. Might kill a lot of people, might kill a few, might not kill any.

I feel like I read this all over the place, verbatim, with regards to COVID-19 back in February/March.

Official Spring Football Guidelines the NCAA will likely rubber stamp these on 9/16.

• Any league or team that plays in the spring may play a maximum of 8 games.
• The spring regular season must conclude no later than April 17th.
• Schools will have a 13 week window in which to play their 8 games, meaning that the first allowable Saturday for football will be January 23rd.
• Schools that play in the spring may hold a Fall practice that follows the rules of typical spring practices. 15 practice sessions in 29 days. Fall practice may be held from mid-September through October.
•Mid-year enrollees and transfers are NOT eligible to play in the spring semester.
• Spring Bowl Games will be allowed.
• Any conferences that postponed, but start a season earlier than the spring outline, may play up to 12 games, but their season can not extend beyond 13 weeks. They may also not hold the prescribed fall practice in Sept/Oct.
• The recruiting dead period has been extended to 10/31.
• Spring teams are currently allowed 12 hours of strength & conditioning, and meetings and 5 hours of on the field practice in helmets.
• Fall teams will be allowed their usual spring practice.
• The 2021-22 season will begin on-time.

https://www.espn.com/college-football/st...ing-season

[quote='UAB Schnauzer' pid='16976928' datelin

. The most infamous of all, thalidomide, was sold as a remedy for morning sickness. Everyone complains about needless regulation slowing down progress. If you child is born with flippers instead of arms you understand some regulation is needed
[/quote]

I remember that calamity during its contested trial. As I recall, only one FDA doctor stood against its clearance for USA distribution. It had been cleared in many European nations and a number of Americans were traveling to Europe to get it or took it while visiting there. That one doctor prevented a greater calamity here.

(09-05-2020 07:30 PM)BAMANBLAZERFAN Wrote:  [quote='UAB Schnauzer' pid='16976928' datelin

. The most infamous of all, thalidomide, was sold as a remedy for morning sickness. Everyone complains about needless regulation slowing down progress. If you child is born with flippers instead of arms you understand some regulation is needed

I remember that calamity during its contested trial. As I recall, only one FDA doctor stood against its clearance for USA distribution. It had been cleared in many European nations and a number of Americans were traveling to Europe to get it or took it while visiting there. That one doctor prevented a greater calamity here.
[/quote]


The Plague? I don’t think there were enough Americans here for a calamity to occur.


Sent from my iPhone using Tapatalk

There was also a Train wreck with a contaminated vaccine in the mid 50’s with the polio vaccine. They were pushing to get massive doses out and one company cut corners.

I want the vaccine yesterday, but haste will kill folks

200,000 nearly in six months have already died.
No haste will definitely kill folks.
Which is better?
Haste will have volunteers.
No haste will take mostly non volunteers.
I don’t know.

(09-04-2020 08:40 AM)blazer-J Wrote:  

(09-03-2020 01:15 PM)BlazerMatt Wrote:  By skipping phase 3 trials which is irresponsible as hell and is going to get a lot of people killed.

Aren't several vaccines in phase 3 now? It seems a few started in late July/early August.

If I remember that stat correctly, the fastest a vaccine has been released is at four years. I understand the urgency, but I'm very leery of something that hits the street that fast, Covid or not.

I don't intend to start a war of political words, but neither the CDC or the NIH is as strongly led as in years past, and there have been people who left or were run off who have not been replaced by scientists as experienced. Many management slots are simply left unfilled.

Heck, I may volunteer for the study. Don’t want to die either. Never was in the military nor a first responder. Maybe I can do something for my self, my family, my community and country.

RedditCFB
@RedditCFB

Sep 8, 2020
Tragic news, Cal U Senior DL Jamain Stephens has passed away. His high school shared a remembrance noting that he suffered from complications of COVID-19.

RedditCFB
@RedditCFB

Jamain Stephens is believed to be the first active NCAA football player to have died after suffering from complications of COVID-19.
4:32 PM · Sep 8, 2020

(09-08-2020 05:01 PM)UAB Band Dad Wrote:  RedditCFB
@RedditCFB

Sep 8, 2020
Tragic news, Cal U Senior DL Jamain Stephens has passed away. His high school shared a remembrance noting that he suffered from complications of COVID-19.

RedditCFB
@RedditCFB

Jamain Stephens is believed to be the first active NCAA football player to have died after suffering from complications of COVID-19.
4:32 PM · Sep 8, 2020

Jamain Stephens

I thought this was an interesting article from the WSJ. Not meant to flame anyone just an interesting retrospective look at football and the 1918 pandemic.

https://www.wsj.com/articles/the-1918-pa...1599048011

So tell me, how does Texas Tech have 75 positives and continue to claim that their players' safety is a priority? How do they continue to play?

https://www.everythinglubbock.com/sports...ing-began/

I guess it boils down to "Get on out there and play sports for our amusement. You got your schollys, move it." SMDH.


I would hope that UAB's coaches, fans, and administration would do better that that.

(09-15-2020 05:08 PM)UAB Band Dad Wrote:  So tell me, how does Texas Tech have 75 positives and continue to claim that their players' safety is a priority? How do they continue to play?

https://www.everythinglubbock.com/sports...ing-began/

I guess it boils down to "Get on out there and play sports for our amusement. You got your schollys, move it." SMDH.


I would hope that UAB's coaches, fans, and administration would do better that that.

Texas Tech is probably one of those programs that we've heard about that subscribed to the "chicken Pox" party theory. Have everyone get it early so they won't have it during the season. LSU said something similar in the last day or so.