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Why the Sudden Hostility Toward Off-Label Medicines?
American Thinker.com ^ | February 7, 2022 | Brian C. Joondeph, MD

Posted on 02/07/2022 3:52:36 AM PST by Kaslin

The US Food and Drug Administration has an exhaustive process, “to evaluate new drugs before they can be sold.” Specifically, this involves the Center for Drug Evaluation and Research (CDER). The rationale is sound and for the general good:

The center's best-known job is to evaluate new drugs before they can be sold. CDER's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Note the goal is neither absolute safety nor perfect efficacy. In other words, no drug is completely safe and without side effects, nor will a drug work every time, exactly as it was designed to. The key is the risk-benefit ratio, where the benefits outweigh the risks or costs.

Otherwise, air travel, driving, and walking would be prohibited as these activities all involve some risk -- but that is far outweighed by their benefits.

Drugs are approved for a specific indication, at a particular dose, and this is on the product label, which is actually the multiple folded paper, attached to the medication container with print so small no one can or wants to read it. It summarizes indications, clinical trial results, side effects, warnings, and dosages, all determined by the registration trials leading to FDA review and approval.

When drugs are used as described by the label, this is referred to as “on-label” use. Insurance companies typically pay for on-label treatment. Conversely, “Unapproved use of an approved drug is often called ‘off-label’ use.” The FDA does not object to this,

(Excerpt) Read more at americanthinker.com ...


TOPICS: Culture/Society; Editorial
KEYWORDS: meds; offlabelmeds
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1 posted on 02/07/2022 3:52:36 AM PST by Kaslin
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To: Kaslin

Psssst, because CoupFlu has NEVER been about public health.


2 posted on 02/07/2022 3:56:43 AM PST by mewzilla (God bless Canada's Freedom Truckers!)
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To: Kaslin

Not only do your marketed drugs need to be tested to be safe, they now also must pass a “Politcal Correctbess Test.

Its beyond ludicrous. The revolt of the People is now in the making.And who will lead it. Trump, DeSantis and Abbot for starters.


3 posted on 02/07/2022 4:15:08 AM PST by Candor7 ((Obama Fascism:http://www.americanthinker.com/2009/05/barack_obama_the_qhttps://uintessentia_1.html))
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To: Kaslin

Simple!!! $$$$$


4 posted on 02/07/2022 5:00:59 AM PST by eeriegeno (Checks and balances??? What checks and balances?)
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To: Kaslin

$$$$$$$ and control.


5 posted on 02/07/2022 5:14:22 AM PST by metmom (...fixing our eyes on Jesus, the Author and Perfecter of our faith….)
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To: Kaslin

Marjorie Taylor Greene for president in 24. So far she is the ONLY leader LOUDLY speaking out to get ivermectin into the hands of Americans AND investigate EVERYONE who has anything to do with the massive cover up that has cost hundreds of thousands of lives. Trump, DeSantis, where the hell are you on this issue that is literally killing thousands of Americans every day?


6 posted on 02/07/2022 5:44:36 AM PST by bramps (It's the Islam, stupid!)
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To: Kaslin

the vilification began because they wanted to get EUA for the vaccines. If there had been other meds that worked, these vaccines would have had to go through the normal routine of approval, which would have taken years.

Was this done to make bucks? of course, but I also think part of the dismissal was so they could go full speed through the EUA.


7 posted on 02/07/2022 6:14:43 AM PST by Katya (lacking in the feelings department, )
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To: Kaslin

Impedes the Population Killoff.


8 posted on 02/07/2022 6:43:15 AM PST by Uncle Miltie (Confirm Janice Rogers Brown!)
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To: metmom; 2ndreconmarine; Fitzcarraldo; Covenantor; Mother Abigail; EBH; Dog Gone; ...
metmom : " $$$$$$$ and control. "

Exactly true ! That is why there is no NIH/FDA/CDC alternative 'OFF LABEL' for covid treatment.
All alternative 'off label' medication procedures have been suppressed, thus leaving only the mRNA 'gene therapy' as the only prescribed treatment
The FED government/ Big Pharma complex has ignored any "off label" treatment, such as ivermectin,
so as to assure the continuation of the authorized under emergency use for big Pharma profits.
I am sure those profits will result in significant donations come re-election time, for the political party that authorized those profits,
or by their subsidized employees.

9 posted on 02/07/2022 8:01:10 AM PST by Tilted Irish Kilt
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To: metmom; Tilted Irish Kilt; All
Speaking of the EUA.....

This is fraudulent:

* 8/23/2021 FDA approved Comirnaty vax.

* 8/24/2021 SecDef issued a mandate because Comirnaty was approved.

* Comirnaty was never produced by Pfizer.

* DOD says non-approved vax will be used to satisfy mandate that legally required an approved vax.— Thomas Massie (@RepThomasMassie) February 7, 2022


10 posted on 02/07/2022 8:31:51 AM PST by Jane Long (What we were told was a “conspiracy theory” in 2020 is now fact. 🙏🏻 Ps 33:12)
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To: Whenifhow; null and void; aragorn; EnigmaticAnomaly; kalee; Kale; azishot; AZ .44 MAG; Baynative; ..

P


11 posted on 02/07/2022 9:47:38 AM PST by bitt ( <img src=' 'width=50%>)
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To: bitt

Re: off-label use being discouraged

In the case of Ivermectin, it has anti-cancer properties:

https://freerepublic.com/focus/f-chat/4036160/posts


12 posted on 02/07/2022 9:55:24 AM PST by WildHighlander57 ((The more you tighten your grip, the more star systems will slip through your fingers.) )
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To: bramps
Ivermectin needs to be stocked next to ibuprofen at the local drugstore. Over the counter. 3 mg and 12 mg tablet sizes. The box needs a dosing table calibrated in weight (pounds) that is easily understood by the purchaser. Stash a box in your home medicine cabinet for use when needed. Same for "Lomotil" for controlling diarrhea. Needed infrequently, but valuable to have on hand when really needed.
13 posted on 02/07/2022 10:14:05 AM PST by Myrddin
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To: Myrddin

Thank you for your reply. Many here seem apathetic towards Ivermectin. It’s very disheartening.


14 posted on 02/07/2022 10:45:59 AM PST by bramps (It's the Islam, stupid!)
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To: Kaslin
It's not all of a "sudden". It has been going on since Fauci took over as head of NIAID and discovered it was a huge pot of taxpayer gold waiting to be mined by the "right" bureaucrat for vast power, influence, and personal wealth.

For the deeply wicked, sickening details read the Robert F. Kennedy Jr. book "The Real Anthony Fauci". I guarantee you won't ever look at government bureaucrats, Big Pharma, and the medical industry the same again. When you do, you will also see a large vision of gallows dancing in your mind.

15 posted on 02/07/2022 10:59:51 AM PST by Gritty (Follow the money in politics, you find the criminals. Is it now true in the medical profession?)
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To: bramps

Many here seem apathetic towards Ivermectin.

~~~~~~~~~

not me -

positive tested for covid, with fever, symptoms of bad flu, ..within 24 hours of ivermectin dose, felt 90%, like a mild cold.
also used Zelenko protocol


16 posted on 02/07/2022 11:00:51 AM PST by bitt ( <img src=' 'width=50%>)
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To: Candor7

What... Abbott is out to lunch.

16 years in Austin and his hallmark is that he is not Beto!

Abbott is as worthless as BLANK on a boar hog.


17 posted on 02/07/2022 11:52:24 AM PST by ptsal (Vote R.E.D. >>>Remove Every Democrat ***)
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To: Candor7

What... Abbott is out to lunch.

16 years in Austin and his hallmark is that he is not Beto!

Abbott is as worthless as BLANK on a boar hog.


18 posted on 02/07/2022 12:00:44 PM PST by ptsal (Vote R.E.D. >>>Remove Every Democrat ***)
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To: ptsal

Well Then, what about Colonel Alan West?


19 posted on 02/07/2022 5:41:19 PM PST by Candor7 ((Obama Fascism:http://www.americanthinker.com/2009/05/barack_obama_the_qhttps://uintessentia_1.html))
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To: Kaslin

No, this is not sudden or surprising.

Democrats, yes democrats, have long attempted to regulate drugs with an iron fist.

Somewhere in a desk drawer of some democrat sits the bill regarding vitamins and supplements too. It is there just waiting to be dusted off for the third time at least ...at regulation that would make it next to impossible to obtain some of the supplements many have been taking to diminish their chances of even getting covid.

It is all going to happen. Sooner or later they are going to come after those who refuse to accept their sorcery.


20 posted on 02/08/2022 3:19:15 AM PST by EBH (Hold My Beer. 1776-2021 May God Save Us.)
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