[fullmetal]

In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power “is reserved to the Secretary.” The bulletin was sent to heads of operating and staff divisions within H.H.S.

It’s unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Political appointees, under pressure from the president, have taken a string of steps over the past few months to interfere with the standard scientific and regulatory processes at the health agencies. For example, a much criticized guideline on testing for the coronavirus was not written by C.D.C. scientists, and was posted on the agency’s public website over their objections. It was reversed on Friday.

It does sound like the FDA is no longer in charge of approving vaccines for public use and that "such power is reserved to the Secretary."  Huh.  This wouldn't be about rushing a vaccine to deployment regardless of the safety data, would it?  Good thing this govt/econ double major from Dartmouth and Yale JD is here to review the clinical data to make sure we're safe from vaccine harm.  Oh, he's just a political appointee without significant clinical research experience?

Sigh.

https://www.nytimes.com/2020/09/19/healt...s-fda.html

[fullmetal]

In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power “is reserved to the Secretary.” The bulletin was sent to heads of operating and staff divisions within H.H.S.

It’s unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Political appointees, under pressure from the president, have taken a string of steps over the past few months to interfere with the standard scientific and regulatory processes at the health agencies. For example, a much criticized guideline on testing for the coronavirus was not written by C.D.C. scientists, and was posted on the agency’s public website over their objections. It was reversed on Friday.

It does sound like the FDA is no longer in charge of approving vaccines for public use and that "such power is reserved to the Secretary."  Huh.  This wouldn't be about rushing a vaccine to deployment regardless of the safety data, would it?  Good thing this govt/econ double major from Dartmouth and Yale JD is here to review the clinical data to make sure we're safe from vaccine harm.  Oh, he's just a political appointee without significant clinical research experience?

Sigh.

https://www.nytimes.com/2020/09/19/healt...s-fda.html

[OutsiderFan]

Awesome! Now my dream of selling “Lead Bread” can become reality. All I need to do is make a campaign contribution to the POTUS and I’ll get FDA to agree with me that when you bake lead in bread dough, the blood poisoning impact goes away at high temperatures, and just adds density to the bread, making it more filling than non-lead based breads. We all know high temps kill bad things, and high temps remove lead toxins, so we know it’s safe. Then I can just partner with the Trump Organization and have the POTUS pitch it to his followers as it’s Official Bread. We can send out videos of him eating a sandwich at the resolute desk saying he’s lost 20 pounds eating sandwiches with this amazing bread. He actually won’t ever eat the Lead Bread, and certainly would not have lost 20 pounds, but nobody will know the difference, certainly not his loyal followers.

[OutsiderFan]

Awesome! Now my dream of selling “Lead Bread” can become reality. All I need to do is make a campaign contribution to the POTUS and I’ll get FDA to agree with me that when you bake lead in bread dough, the blood poisoning impact goes away at high temperatures, and just adds density to the bread, making it more filling than non-lead based breads. We all know high temps kill bad things, and high temps remove lead toxins, so we know it’s safe. Then I can just partner with the Trump Organization and have the POTUS pitch it to his followers as it’s Official Bread. We can send out videos of him eating a sandwich at the resolute desk saying he’s lost 20 pounds eating sandwiches with this amazing bread. He actually won’t ever eat the Lead Bread, and certainly would not have lost 20 pounds, but nobody will know the difference, certainly not his loyal followers.

[dabigv13]

The only way we won't see some emergency approval before the election is if in the next few weeks all of the Phase III trials have big-time safety incidents. And even then I bet Azar would find a way to emrgency approve something.

Trump has politicized so many facets of American life, so this is hardly surprising.

[dabigv13]

The only way we won't see some emergency approval before the election is if in the next few weeks all of the Phase III trials have big-time safety incidents. And even then I bet Azar would find a way to emrgency approve something.

Trump has politicized so many facets of American life, so this is hardly surprising.

[BostonCard]

Eric Topol (known for having identified the safety issues in Vioxx), weighs in:

[tweet]https://twitter.com/EricTopol/status/1307381521745997824?s=20[/tweet]

It's a very good thread about what it would take to get an EUA for a vaccine.  Basically, per the stats, the Pfizer study can have a look once they reach 32  events (COVID-19 infections), and the DSMB can declare efficacy if 26 of those 32 occur in the placebo arm.  That is pretty overwhelming evidence of efficacy.  This would be a 77% efficacy, with a confidence interval of 44 to 92%, which would easily satisfy the FDA's requirements.

What you wouldn't be able to figure out is whether the vaccine reduced severe COVID-19 pneumonia (hospitalizations) or affected deaths, because you almost certainly wouldn't have enough severe COVID-19 cases to be able to tell.  It would not be unheard of for a vaccine to reduce the risk of developing a disease, but if people did get it, they were more likely to get a serious version.  This happened with the dengue vaccine, for example.

BC

[BostonCard]

Eric Topol (known for having identified the safety issues in Vioxx), weighs in:

[tweet]https://twitter.com/EricTopol/status/1307381521745997824?s=20[/tweet]

It's a very good thread about what it would take to get an EUA for a vaccine.  Basically, per the stats, the Pfizer study can have a look once they reach 32  events (COVID-19 infections), and the DSMB can declare efficacy if 26 of those 32 occur in the placebo arm.  That is pretty overwhelming evidence of efficacy.  This would be a 77% efficacy, with a confidence interval of 44 to 92%, which would easily satisfy the FDA's requirements.

What you wouldn't be able to figure out is whether the vaccine reduced severe COVID-19 pneumonia (hospitalizations) or affected deaths, because you almost certainly wouldn't have enough severe COVID-19 cases to be able to tell.  It would not be unheard of for a vaccine to reduce the risk of developing a disease, but if people did get it, they were more likely to get a serious version.  This happened with the dengue vaccine, for example.

BC

[82 Card]

Eric Topol (known for having identified the safety issues in Vioxx), weighs in:



[tweet]https://twitter.com/EricTopol/status/1307381521745997824?s=20[/tweet]


....

I thought the story was that either the virus itself or reports of the virus threatening life were a hoax? Now they're going to declare something as possibly effective against a hoax? I guess consistency is the hobgoblin of little minds.

[82 Card]

Eric Topol (known for having identified the safety issues in Vioxx), weighs in:



[tweet]https://twitter.com/EricTopol/status/1307381521745997824?s=20[/tweet]


....

I thought the story was that either the virus itself or reports of the virus threatening life were a hoax? Now they're going to declare something as possibly effective against a hoax? I guess consistency is the hobgoblin of little minds.

[Goose]

Eric Topol (known for having identified the safety issues in Vioxx), weighs in:



[tweet]https://twitter.com/EricTopol/status/1307381521745997824?s=20[/tweet]


....

I thought the story was that either the virus itself or reports of the virus threatening life were a hoax? Now their going to declare something as possibly effective against a hoax? I guess consistency is the hobgoblin of little minds.

Being effective against a hoax is a pretty low bar isn't it? In fact, an empty vial defeats a hoax I believe.

[Goose]

Eric Topol (known for having identified the safety issues in Vioxx), weighs in:



[tweet]https://twitter.com/EricTopol/status/1307381521745997824?s=20[/tweet]


....

I thought the story was that either the virus itself or reports of the virus threatening life were a hoax? Now their going to declare something as possibly effective against a hoax? I guess consistency is the hobgoblin of little minds.

Being effective against a hoax is a pretty low bar isn't it? In fact, an empty vial defeats a hoax I believe.