Why?

[paindonthurt_]

https://www.cnn.com/2022/01/25/us/florida-closing-monoclonal-antibody-treatment-sites/index.html

 

[aTotal360]

I'm fine with your doctor saying it's ineffective. But allowing the govt to step in just stinks to high heaven.

 

[Maroon Eagle]

The answer is in the headline.

 

[Drebin]

The answer is in the headline.

The issue here is that the government stripped the designation without notice, and over 2000 appointments had to be abruptly canceled, while there are many physicians out there who disagree with the FDA's assessment, and believe that it is effective.

This was a spectacularly ****** move by the FDA that would be getting called out more vociferously if we had an honest press in this country.

 

[The Peeper]

CNN toting the water water for though. I'd click on Clarion Ledger before CNN and there's little chance of that even

 

[dorndawg]

Did you hear about the guy who lost his whole left side? He turned out all right.

 

[Maroon Eagle]

I thought you'd be against continued ineffective treatment as it'd be a waste of time and money.

This move - which I agree is abrupt - is ultimately philosophically and logically conservative.

 

[Drebin]

I thought you'd be against continued ineffective treatment as it'd be a waste of time and money.

This move - which I agree is abrupt - is ultimately philosophically and logically conservative.

I don't have a problem with it under certain conditions:

1. The ineffectiveness has to be a consensus decision. There are a lot of doctors that disagree.
2. It can't be abrupt like this. That was very disruptive for a lot of people.
3. While omicron is the dominant variant, it's not the only variant.

It's best to be more measured than this. It's best to release scientific data to back the decision and give physicians an opportunity to evaluate and agree/disagree/come up with alternative solutions. None of that happened here.

 

[Arthur2478]

Why?

Because they want people to think the only way out of this is vaccination. The left has been anti-treatment of the infected ever since the vaccine came out. It's asinine. You can promote vaccination and treatment. It doesnt have to be one or the other.

 

[Bill Shankly]

If it doesn't work it doesn't work. This isn't abrupt by the way. It's been in the works for at least a couple of weeks.

 

[the dog is on the loose]

Idiots are saying that the monoclonal antibodys have side effects that are potentionally serious such as diarrhea,nausea,dizziness,etc but yet the side effects of the vaccines are potentionally way worse but lets just go ahead and shut down the monclonal. Im beyond sick of the politics of all this crap!!

 

[Maroon Eagle]

We agree.

But we then need to follow up and check the footnotes.

Based on Centers for Disease Control and Prevention data, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15. Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time. This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant.

Taken from the FDA release: Link.

If you've got 99 percent of folks with Omicron and monoclonal is shown not to be effective, then you shelve it for the time being.

That's my thought.

 

[Drebin]

We agree.

But we then need to follow up and check the footnotes.



Taken from the FDA release: Link.

If you've got 99 percent of folks with Omicron and monoclonal is shown not to be effective, then you shelve it for the time being.

That's my thought.

The only point I'm making is that there are doctors who disagree with the assessment that they're not effective. In the article, the FDA is throwing its weight behind the Glaxo version and dismissing the others, which is at least curious.

The vaccines have also been demonstrated to be not as effective against omicron, and actually does nothing to prevent infection. So why does the FDA choose to be selectively dishonest here? If side effects for the monochlonal antibodies are part of the determining factor here, why is that the case, since those side effects are milder than the vax side effects?

I'm not anti vax. I have been vaxxed and boosted. It didn't stop me from getting a joyless case of covid three weeks ago.

There's way too much mixed messaging and politically opportunistic decision making coming from our government. Let doctors do their job. If a doctor believes in this therapy, don't take it away from him.

 

[Dawgg]

The only point I'm making is that there are doctors who disagree with the assessment that they're not effective. In the article, the FDA is throwing its weight behind the Glaxo version and dismissing the others, which is at least curious.

It says in the article that Regeneron itself says their version is not as effective against omicron.

On January 7, DeSantis said he'd secured 15,000 doses of Regeneron's antibody treatment for the state, despite the pharmaceutical company saying in December its REGEN-COV antibodies "have diminished potency against Omicron."

 

[Drebin]

It says in the article that Regeneron itself says their version is not as effective against omicron.

On January 7, DeSantis said he'd secured 15,000 doses of Regeneron's antibody treatment for the state, despite the pharmaceutical company saying in December its REGEN-COV antibodies "have diminished potency against Omicron."

Diminished potency is not the same thing as ineffective. If that was the case, the FDA would also be withdrawing emergency authorization for the Phizer and Moderna vaccines, which have also been acknowledged to have diminished potency against Omicron.

 

[Hump4Hoops]

It's okay to be "anti-treatment" when the "treatment" is ********.

Hydroxycholoroquine. Bleach. Horse de-wormer. Human urine.

 

[thekimmer]

I'm fine with your doctor saying it's ineffective. But allowing the govt to step in just stinks to high heaven.

It is wholly the FDA's responsibility to determine safety and efficacy of all drugs, devices and biologics. Your individual physician is not qualified nor does he/she generally have sufficient data to make such a judgement. Clinical data does factor into safety and efficacy determination but usually involves blinded clinical trials as well as nonclinical data. I can't say whether or not FDA got this one right or wrong but I can say it is completely their call to make.

I have dealt with the FDA for 36 years and from my perspective I can truthfully say that while I do not agree with many of their decisions/policies I have found those I have dealt with in the agency to operate for the most part in good faith and actually collaboratively with industry in many instances such as in standards development for emerging technologies. Definitely not with a political agenda like the CDC has become. At least not yet.

 

[LocalBeachBum]

Kind of like the vaccines? Which are still being used? Still killing people, causing strokes, Bell’s palsy, heart problems?

like that?

it would be laughable if it weren’t true.

the government is willing to sacrifice young and old to force them to get their jabs.